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

Catalog Number	816022100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our fnal report on this incident.
Event or Problem Description
The customer reported a false positive reaction with cell no.4 (donor no.(b)(6)) of biotestcell-i11 plus with the anti-m reagent of the competitor grifols.The customer announced to ship the complaint sample for investigational testing.In the meantime, our quality control laboratory tested cell no.4 (donor (b)(6)) with seraclone anti-m, seraclone anti-n, seraclone anti-s and seraclone anti-s and confirmed the reaction pattern of the antigen table of donor (b)(6) regarding the mns system: nnss.We did not observe any positive reaction with seraclone anti-m.Additionally, cell no.4 (donor (b)(6)) was tested with a polyclonal anti-m.Again, the reaction was clearly negative.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.When we received the product sample returned by the customer, our quality control laboratory tested cell 4 (donor no.(b)(6)) with the blood grouping reagents seraclone anti-m, seraclone anti-n, seraclone anti-s and seraclone anti-s and confirmed the reaction pattern of the antigen table of donor (b)(6) regarding the mns system: nnss.We did not observe any positive reaction with seraclone anti-m.Additionally, cell 4 (donor no.(b)(6)) was tested with a polyclonal anti-m.Again, the reaction was clearly negative.Based on the investigation the complaint was classified as confirmed - epp (expected product performance).The complaint sample and the retention sample reacted as expected.Based on the information provided for the anti-m blood grouping reagent of grifols a sample of the donor of cell 4 (donor (b)(6)) was serologically tested for the henshaw antigen.The presence of this antigen was confirmed serologically.The presence of the henshaw (mns6) antigen in donor (b)(6) was the most probable explanation for the positive reaction at the customer with the grifols anti-m bood grouping reagent.The chapter "specific performance characteristics" of the instruction for use (ifu) of the monoclonal anti-m blood grouping reagent of grifols contained the appropriate note that " anti-m can recognize unspecifically some henschaw red blood cells (m-, he+ is an extremely rare phenotype)." an incorrect antigen table of the biotestcell-i11 plus with regard to the mns antigens of the donor (b)(6) could be clearly excluded.
Event or Problem Description
The customer reported a false positive reaction with cell no.4 (donor no.(b)(6)) of biotestcell-i11 plus with the anti-m reagent of the competitor grifols.The customer announced to ship the complaint sample for investigational testing.In the meantime, our quality control laboratory tested cell no.4 (donor (b)(6)) with seraclone anti-m, seraclone anti-n, seraclone anti-s and seraclone anti-s and confirmed the reaction pattern of the antigen table of donor 990015 regarding the mns system: nnss.We did not observe any positive reaction with seraclone anti-m.Additionally, cell no.4 (donor (b)(6)) was tested with a polyclonal anti-m.Again, the reaction was clearly negative.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Additional Manufacturer Narrative
This is our initial report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL-I 11 PLUS
• Common Device Name: BIOTESTCELL-I 11 PLUS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 19161524
• Report Number: 9610824-2024-00009
• Device Sequence Number: 7855949
• Product Code: QHT
• UDI-Device Identifier: 07611969952441
• UDI-Public: (01)07611969952441(17)240506(10)9410011-00
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup

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: 05/06/2024
• Device Catalogue Number: 816022100
• Device Lot Number: 9410011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GRIFOLS ANTI-M.; GRIFOLS ANTI-M.
• Patient Sex: Unknown