ALINITY I B12 REAGENT KIT
Received Dec 20, 2021 · Event occurred Dec 9, 2021
Report 3005094123-2021-00249 · MDR key 13043850
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
A.i.d.d LongfordCatalog number
07P67-32
Lot number
30472UD00
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
POSTAL CODE: A LEADING ZERO WAS ADDED TO THE FIELD BECAUSE THE SYSTEM REQUIRES A MINIMUM OF 5 DIGITS IN THE POSTAL CODE FIELD. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P67-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P67-21/-31. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER OBTAINED DISCREPANT ALINITY I B12 RESULTS FOR A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (CUSTOMER NORMAL RANGE: 220 PG/ML) SID (B)(4) MEASURED ON (B)(6) 2021 IN PG/ML: AT 2:23 PM = 150. AT 3:50 PM = 247. AT 4:36 PM = 210. AT 5:47 PM = 319. THE CUSTOMER IS UNSURE WHICH RESULTS ARE THE CORRECT RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR IMPRECISE/ABERRANT ALINITY I B12 RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. THE COMPLAINT ACTIVITY REVIEW DETERMINED NORMAL COMPLAINT ACTIVITY FOR THE REAGENT LOT. TRACKING AND TRENDING WAS REVIEWED AND DID NOT IDENTIFY ANY RELATED TRENDS. ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT OF THE COMPLAINT LOT 30472UD00 STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE REAGENT LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY FOR ALINITY I B12 REAGENT LOT 30472UD00 WAS IDENTIFIED.G1 ALL MANUFACTURERS: G1 - CONTACT INFORMATION HAS BEEN UPDATED TO INCLUDED NEW CONTACT NAME, EMAIL, ADDRESS, PHONE NUMBER, AND FAX NUMBER.