MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL® -I 11 PLUS; BIOTESTCELL®-I 11 PLUS; 11X4ML

Catalog Number	816022100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported that cell #10 of biotestcell-i11 plus (donor (b)(6)) showed a false negative reaction with anti-kpb.According to the antigen table donor (b)(6) is kpa-b+.The customer did neither provide the complaint sample biotestcell-i11 plus for investigational testing nor the reagent that had caused the false negative test result.Therefore our quality control laboratory tested their retention sample of biotestcell-i11 plus of the supposedly defective lot with three different anti-kpb.The used anti-kpb were: anti-kpb lot 2038020-00 (finished product), anti-kpb (high frequent plasma) and id-antigen profile ii.Cell #10 of biotestcell-i11 plus showed clearly positive reactions with all three antisera.Based on our investigation we could not confirm the customer's finding.A mistyping in the antigen table could be excluded.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® -I 11 PLUS
• Common Device Name: BIOTESTCELL®-I 11 PLUS; 11X4ML
• 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: 14539265
• Report Number: 9610824-2022-00029
• Device Sequence Number: 5172929
• Product Code: QHT
• UDI-Device Identifier: 07611969952441
• UDI-Public: (01)07611969952441(17)220606(10)9214011-00
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/30/2022

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: 06/06/2022
• Device Catalogue Number: 816022100
• Device Lot Number: 9214011-00
• 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: 05/05/2022
• Initial Report FDA Received Date: 05/30/2022
• 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