MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL-3; BIOTESTCELL 3

Catalog Number	816085100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant results during antibody screen testing on a rhogam patient using biotestcell 3 on tango infinity.An initially weak positive result was negative when retested.The customer announced to provide the original samples for investigational testing but so far, we have not received them.The information, which lot of biotestcell 3 was used for testing, was only provided on september 27, 2024.At that ime the product had already expired (september 23, 2024).Therefore, it was not possible to test the retention sample of the affected lot.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The investigation 0f the affected tango infinity instrument is still ongoing.
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported discrepant results during antibody screen testing on a rhogam patient using biotestcell 3 on tango infinity.Initially the patient reacted weakly positive but negative reactions were obtained upon retesting.The information, which lot of biotestcell 3 was used for testing, was only provided on september 27, 2024.At that ime the product had already expired (september 23, 2024).Therefore it was not possible to test the retention sample of the affected lot.The customer initially announced to provide the original samples for investigational testing but did not send them in.Therefore we were not able to investigate the reported issue any further.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Also, no log files of the affected tango infinity were provided, therefore a further investigation of the instrument was not possible.Based on the investigation the complaint was classified as undetermined.The customer was not interested in any further investigation, therefore neither instrument files nor the affected patient sample were provided.An expedient invesgtigation was therefore not possible.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL-3
• Common Device Name: BIOTESTCELL 3
• 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: 20342381
• Report Number: 9610824-2024-00045
• Device Sequence Number: 12789219
• Product Code: QHT
• UDI-Device Identifier: 07611969952687
• UDI-Public: (01)07611969952687(17)240923(10)9430021-00
• 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,Followup
• Report Date (Section B): 10/30/2024

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: 09/23/2024
• Device Catalogue Number: 816085100
• Device Lot Number: 9430021-00
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/30/2024
• 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: TANGO INFINITY, SN (B)(6); TANGO INFINITY, SN (B)(6)
• Patient Sex: Unknown