TRIAGE D-DIMER PANEL
Received Dec 9, 2016
Report 2027969-2016-00701 · MDR key 6159947
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
98100EULot number
W62131RBA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62131. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W62131 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. FURTHER INVESTIGATION WAS NOT POSSIBLE SINCE THE CUSTOMER DID NOT RETURN ANY SAMPLES FOR TESTING. UNABLE TO DETERMINE A ROOT CAUSE FROM THE AVAILABLE INFORMATION. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.
Description of Event or Problem
EVENT OCCURRED IN (B)(6). THE CUSTOMER REPORTED RECEIVING A FALSE NEGATIVE RESULT WITH TRIAGE D-DIMER PANEL FROM LOT W62131RBA. THE CUSTOMER RECEIVED A NEGATIVE RESULT OF <100. THE CUSTOMER TESTED WITH EDTA WHOLE BLOOD. THE OTHER GP OF THE PATIENT SENT A SAMPLE FOR CONFIRMATORY TESTING TO A LAB ON THE SAME DAY AND THEY RECEIVED A POSITIVE RESULT OF 694. THE PATIENT'S SPECIMEN WAS SENT TO THE LAB IN A CITRATE TUBE. THERE WERE NO REPORTED ADVERSE EVENTS RELATED TO THE TRIAGE RESULT. NO ADDITIONAL INFORMATION PROVIDED.