SPECIMEN DILUENT
Received Nov 26, 2024 · Event occurred Oct 21, 2024
Report 1034569-2024-00021 · MDR key 20788890
Device
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO SPECIFIC ROOT CAUSE OR DEFECT WAS IDENTIFIED. NO PRODUCT OR SAMPLE WAS RETURNED TO IMMUCOR FOR ADDITIONAL TESTING. THE CONCLUSION(S) CODE(S) REPORTED HEREIN ARE ASSIGNED ACCORDING TO THE FACTS PRESENTED BY THE AFFECTED CUSTOMER AND IMMUCOR'S ASSESSMENT AND INVESTIGATION OF THOSE FACTS. THERE IS NO SPECIFIC ACTION THAT USERS ARE EXPECTED TO TAKE TO MITIGATE THE REPORTED DEVICE FAILURE/MALFUNCTION OTHER THAN TO FOLLOW INSTRUCTIONS FOR USE. LABELING CONTAINS THE FOLLOWING LIMITATION: "ERRONEOUS TEST RESULTS CAN OCCUR FROM BACTERIAL OR CHEMICAL CONTAMINATION OF THE SPECIMEN DILUENT (OR BLOOD SPECIMEN), IMPROPER STORAGE OF THE SPECIMEN DILUENT (OR BLOOD SPECIMEN)".
Description of Event or Problem
A CUSTOMER SITE IN THE UK REPORTED RECEIVING AN UNEXPECTED NEGATIVE REACTION ON A DONOR UNIT WITH KNOWN HETEROZYGOUS S+S+ PHENOTYPE.