ACTIMPROM POC TEST 10/BOX
Received Dec 4, 2020 · Event occurred Oct 25, 2020
Report 1216677-2020-00288 · MDR key 10949999
Device
Generic name
Actimprom Poc Test 10/box
Manufacturer
Coopersurgical Inc.Model number
30800ETUSCatalog number
30800ETUS
Lot number
-
Product problems
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION: X-NO SAMPLE RETURNED. ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM (B)(4). 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: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: 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 : 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 COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. 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
(B)(4). PATIENT 2= ACTIM PROM COLLECTED AT 2154 REPORTED ACTIM POSITIVE AT 2225. DR. NOTIFIED. DR. AT BEDSIDE (B)(6) 20 AT 0912 INDICATED THAT AMNIOTIC SAC STILL INTACT AND PERFORMED RUPTURE OF MEMBRANES. ACTIMPROM POC TEST 10 BOX 30831ETUS (B)(4).
Additional Manufacturer Narrative
COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.
Description of Event or Problem
(B)(4). PATIENT 2= ACTIM PROM COLLECTED AT 2154 REPORTED ACTIM POSITIVE AT 2225. DR. NOTIFIED. DR. AT BEDSIDE (B)(6) 2020 AT 0912 INDICATED THAT AMNIOTIC SAC STILL INTACT AND PERFORMED RUPTURE OF MEMBRANES. 1216677-2020-00288 ACTIMPROM POC TEST 10 BOX 30831ETUS (B)(4).