ACTIMPROM POC TEST 10/BOX

Additional Manufacturer Narrative

INVESTIGATION X-NO SAMPLE RETURNED ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM ACTIM OY ON 05/03/2019 AND SOLD ON 10/12/2020. MANUFACTURING RECORD REVIEW MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW IQC RECORD-19-05-06-012 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

Description of Event or Problem

E-COMPLAINT-(B)(4). ADDITIONAL COMPLAINT IN REF. TO E-COMPLAINT-(B)(4). REPORT STATED - ONE OF THE LABOR AND DELIVERY NURSES IS REPORTING THAT SHE HAS SEEN 2 PATIENTS WITH RUPTURE OF MEMBRANES THAT HAVE HAD A NEGATIVE ACTIMPROM RESULT. "AS A TRIAGE NURSE IN LABOR AND DELIVERY, I HAVE EXPERIENCED TWO DIFFERENT OCCASIONS WHERE THE PATIENT IS GROSSLY RUPTURED/ AMNIOTIC FLUID IS POURING OUT, AND YET THE ACTIMPROM SPECIMEN COMES BACK NEGATIVE. I BELIEVE THAT THIS COULD BE UNSAFE IF THERE IS A POSSIBILITY THAT WE ARE SENDING PATIENTS HOME WHEN THEY ARE RUPTURED/LEAKING, ESPECIALLY IF THEY ARE PRETERM. THANK YOU" ADDITIONAL INFO DETAILS OF THE EVENT ARE MOM AND BABY WELL? YES. WHERE ANY ADDITIONAL STEPS TAKEN AFTER THE QUESTIONED ACTIM PROM RESULTS TO CONFIRM MEMBRANE STATUS OR MANAGE THE DELIVERY? NOT THAT I CAN FIND IN THE EMR. HOW LONG AFTER THE ACTIM PROM TEST DID LABOR START AND DELIVERY OCCUR? MEMBRANES RUPTURED AT (B)(6) 2021 AT 23:07 (BEFORE ADMITTANCE TO HOSPITAL). LABOR DOCUMENTED AT (B)(6) 2021 AT 00:00 (CONTRACTIONS 7-8 MINUTES APART, 2 CM DILATED). DELIVERY AT (B)(6) 2021 AT 09:46. WHAT IS THE LOT NUMBER FOR THE ACTIM PROM TEST KITS IN USE WHEN THE PATIENT WAS TESTED? ACTIMPROM TEST ON (B)(6) 2021 AT 00:25 LOT # 0042546. 1216677-2021-00047 ACTIMPROM POC TEST 10-BOX 30831ETUS E-COMPLAINT-(B)(4).

Additional Manufacturer Narrative

COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

Description of Event or Problem

E-COMPLAINT: (B)(4). ADDITIONAL COMPLAINT IN REF. TO E-COMPLAINT: (B)(4). REPORT STATED - ONE OF THE LABOR AND DELIVERY NURSES IS REPORTING THAT SHE HAS SEEN 2 PATIENTS WITH RUPTURE OF MEMBRANES THAT HAVE HAD A NEGATIVE ACTIMPROM RESULT. "AS A TRIAGE NURSE IN LABOR AND DELIVERY, I HAVE EXPERIENCED TWO DIFFERENT OCCASIONS WHERE THE PATIENT IS GROSSLY RUPTURED/ AMNIOTIC FLUID IS POURING OUT, AND YET THE ACTIMPROM SPECIMEN COMES BACK NEGATIVE. I BELIEVE THAT THIS COULD BE UNSAFE IF THERE IS A POSSIBILITY THAT WE ARE SENDING PATIENTS HOME WHEN THEY ARE RUPTURED/LEAKING, ESPECIALLY IF THEY ARE PRETERM. THANK YOU". ADDITIONAL INFO DETAILS OF THE EVENT: ARE MOM AND BABY WELL? YES. WHERE ANY ADDITIONAL STEPS TAKEN AFTER THE QUESTIONED ACTIM PROM RESULTS TO CONFIRM MEMBRANE STATUS OR MANAGE THE DELIVERY? NOT THAT I CAN FIND IN THE EMR. HOW LONG AFTER THE ACTIM PROM TEST DID LABOR START AND DELIVERY OCCUR? MEMBRANES RUPTURED AT (B)(6) 2021 AT 23:07 (BEFORE ADMITTANCE TO HOSPITAL). LABOR DOCUMENTED AT (B)(6) 2021 AT 00:00 (CONTRACTIONS 7-8 MINUTES APART, 2 CM DILATED). DELIVERY AT (B)(6) 2021 AT 09:46. WHAT IS THE LOT NUMBER FOR THE ACTIM PROM TEST KITS IN USE WHEN THE PATIENT WAS TESTED? ACTIMPROM TEST ON (B)(6) 2021 AT 00:25 LOT # 0042546. ACTIMPROM POC TEST 10-BOX 30831ETUS. E-COMPLAINT: (B)(4).