MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL A2

Catalog Number	816047100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined intital and final report on this incident.
Event or Problem Description
The customer reported false positive reactions of biotestcell-a2 during manual testing.She stated that a patient sample with a known cold agglutinin and the hemobioscience control qc1 (blood group a rh negative, no antibodies) showed the false positive reactions.The customer did neither return the complaint sample biotestcell-a2 for investigational testing nor the specimens that had caused the false positive test results.When the customer announced that she wold provide her complaint sample and the qc after all, both had already expired.Therefore, we did not request them any longer.Our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples.The testing was performed manually according to the instruction for use (ifu).The tests were performed as immediate spin test and with an incubation for 30 minutes at room temperature.In all cases the positive and negative reactions were correct.We did not observe any false positive reaction.Based on the investigation the complaint was classified as undetermined.The complaint sample was not available, and the retention sample reacted as expected.Because neither the complaint sample nor the specimens that caused the false positive reactions were available, the root cause of the false positive reactions at the customer´s site remains unknown.Especially since the customer had reported that in a repeat test conducted with a prolonged incubation according to the ifu, the reactions were negative.The positive reaction of the patient sample might be explainable by the presence of the known cold agglutinin, but not the positive reaction of the hemobioscience control qc1.We did not receive any other complaints regarding this complaint reason.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL A2
• Common Device Name: BIOTESTCELL A2
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 13867914
• Report Number: 9610824-2022-00014
• Device Sequence Number: 14625705
• Product Code: QHT
• UDI-Device Identifier: 07611969952625
• UDI-Public: (01)07611969952625(17)220314(10)9202011-00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 125207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2022
• Device Catalogue Number: 816047100
• Device Lot Number: 9202011-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown