MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL A1&B

Catalog Number	816057100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 unexpected positive reactions of patient samples with biotestcell a1&b in the reverse typing.The customer stated that she a patient sample with an anti-m caused interferences with biotestcell a1&b.Furthermore, the customer stated that the reverse typing reagent red blood cells of ortho would be m antigen negative.The dustomer did not provide a date of event.The customer did neither return a product sample of biotestcell a1&b, lot 9402011-00 for investigational testing nor the patient sample that showed interferences.Therefore, our quality control laboratory tested their retention samples of the current lots of biotestcell a1&b: lot 9402011-00 (lot the customer filed her complaint for), lot 9406011-00 and lot 9410011-00 with different donor samples according to the instruction for use (ifu).All acceptance criteria were met.We did not observe any false positive reaction.Within the production process biotestcell a1&b was tested for the abo bloodgroups, the rh phenotypes and the antigens kell (kel1) and cellano (kel2) according to the requirements.The acceptance criteria were met.Testing for further antigens was not mandatory.Based on the investigation the complaint was classified as undetermined.Neither the complaint sample nor the patient samples that had caused the interferences were available and the retention sample reacted as expected.For abo products there are no specifications for the testing of antigens beyond abo, rh (rh phenotype), k (kel1), k (kel2).The testing for further antigens is not mandatory.Due to the test method for the reverse typing, it would be possible that antibodies that have a reaction optimum below 37 degrees c show a positive result in the reverse typing, depending on the antigens of the reagent red blood cells used and the specificity of the antibody.We therefore referred the customer to the section "limitations" of the instruction for use: false positive reactions might occur due to: cold antibodies.Auto antibodies.Panagglutinins.Patient's medication (e.G.Antibiotics, plasma expanders of high molecular weight).A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Initially, this complaint was considered not to meet the criteria for vigilance reporting to fda.The complaint was re-classified as being "reportable" on may 05, 2024 and the timeline of 30 days for submitting an mdr report to fda has been exceeded.An internal quality notification has been opened to document this delay.((b)(4)).

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL A1&B
• Common Device Name: BIOTESTCELL A1&B
• 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: 19357772
• Report Number: 9610824-2024-00014
• Device Sequence Number: 3851513
• Product Code: QHT
• UDI-Device Identifier: 07611969952663
• UDI-Public: (01)07611969952663(17)240311(10)9402011-00
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/21/2024

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: 03/11/2024
• Device Catalogue Number: 816057100
• Device Lot Number: 9402011-00
• 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: 03/05/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ORTHO REVERSE CELLS
• Patient Sex: Unknown