MalfunctionLIM
FMH RAPIDSCREEN
Received Sep 4, 2014 · Event occurred Aug 8, 2014
Report 1034569-2014-00163 · MDR key 4060889
Device
Generic name
Test, Screening, For D Positive Fetal Rbc's
Manufacturer
Immucor, Inc.Catalog number
0007893
Lot number
24516
Product problems
- False Negative Result
Patient
39 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING FMH RAPIDSCREEN.
Additional Manufacturer Narrative
IMMUCOR LABORATORY RECEIVED RETURNED SAMPLE (B)(4) ON (B)(4) 2014, HOWEVER WAS UNABLE TO TEST IT BECAUSE IT WAS BEYOND THE PRESCRIBED USABILITY DATES. THE IMMUCOR LABORATORY DID HOWEVER TEST RETENTION FMH RAPIDSCREEN PRODUCT WHICH PERFORMED AS EXPECTED.