MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

Catalog Number	816 014100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported inconsistent results of a cap survey sample with biotestcell 1&2 on the tango infinity.The customer tested the cap survey sample several times on tango infinity and in most cases the reactions were positive with cell #1 of biotestcell 1&2 but in two cases they were negative.The customer stated that they also tested the cap survey sample with biotestcell 1&2 in the tube method and received a positive result.The customer did neither return the complaint sample for investigational testing nor the cap survey sample.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot on tango infinity.The tests were performed using positive and negative control, different donor samples and two known antibodies (anti-k and anti-m) from interlaboratory comparison testing.All positive and negative reactions were correct.The two known antibodies were processed three times on the tango infinity.They showed the same correct result in each run.We did not observe any false negative or inconsistent results.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The investigation of 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 inconsistent results of a cap survey sample with biotestcell 1&2 on the tango infinity.The customer tested the cap survey sample several times on the tango infinity and in most cases the reactions were positive with cell #1 of biotestcell 1&2 but in two cases they were negative.The customer stated that they also tested the cap survey sample with biotestcell 1&2 in the tube method and received a positive result.The customer did neither return the complaint sample for investigational testing nor the cap survey sample.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot on tango infinity.The tests were performed using positive and negative control, different donor samples and two known antibodies (anti-k and anti-m) from interlaboratory comparison testing.All positive and negative reactions were correct.The two known antibodies were processed three times on the tango infinity.They showed the same correct result in each run.We did not observe any false negative or inconsistent results.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Databases and log files of the affected tango infinity were analyzed thoroughly.There was no hint for a device malfunction.All qc results in the reviewed period look fine.The incubations times were checked and all times were in spec between 20 and 22 minutes.The provided image shows some structure around the center, so it could be rated at least as a +/- reaction.Based on the investigation the complaint was classified as undetermined: the complaint sample was not available for investigation and the retention sample reacted as expected.The cap survey sample in question was not available for further investigation.Neither the specificity of the antibody nor the nature of the cap survey sample is known.The variation of the reaction strengths of the cap survey sample remains unexplained.The investigation of the instrument data did not show any sign for a device malfunction.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 1&2
• Common Device Name: BIOTESTCELL 1&2
• 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: 17376987
• Report Number: 9610824-2023-00037
• Device Sequence Number: 17813738
• Product Code: QHT
• UDI-Device Identifier: 07611969952380
• UDI-Public: (01)07611969952380(17)230703(10)9318011-00
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 08/24/2023

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: 07/03/2023
• Device Catalogue Number: 816 014100
• Device Lot Number: 9318011-00
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TANGO INFINITY, SN (B)(6).; TANGO INFINITY, SN (B)(6).
• Patient Sex: Unknown