MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL POOL; BIOTESTCELL POOL, 10 ML

Catalog Number	816065100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative reaction of a patient sample with biotestcell pool.The specificity of the missed antibody was anti-k.The customer performed the test manually.The customer announced to send in samples for investigational testing.We are still waiting for the patient sample that caused false negative.In the meantime our quality control tested the supposedly defective product with two different anti-k reagents and yielded correctly positive results.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 final report on this incident.
Event or Problem Description
The customer reported a false negative result of a patient sample with biotestcell pool (ref #816065100, lot #8015011-00) on tango infinity.The customer stated that the patient was tested at another facility and the specificity of the missed antibody was anti-k (kel1).The customer did neither return the complaint sample for investigational testing nor the patient sample that had caused a false negative test result.Therefore our quality control laboratory tested their retention sample of biotestcell pool (ref 816065100, lot 8015011-00) with seraclone anti-k in the tube test with an incubation for 5 minutes at room temperature and with a polyclonal anti-k in the indirect antiglobulin test (iat).The pooled cell (donor (b)(6), k+k+) yielded a correct positive result in both tests.The customer did not provide result images or the log files for analysis of the tango infinity's function.Last preventive maintenance was in january 2020.Without log files an analysis of the instrument's function is not possible.According to the field service engineer the instrument was running within specification.Because the complaint sample was not available for investigation, the retention sample reacted as expected and the patient sample has not been provided for further investigation, the root cause of the false negative result at customer´s site remained unknown.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 POOL
• Common Device Name: BIOTESTCELL POOL, 10 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 10199007
• Report Number: 9610824-2020-00040
• Device Sequence Number: 3232859
• Product Code: QHT
• UDI-Device Identifier: 07611969952670
• UDI-Public: (01)07611969952670(17)200608(10)8015011-00
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 06/08/2020
• Device Catalogue Number: 816065100
• Device Lot Number: 8015011-00,
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOTESTCELL 1&2, LOT 8015011-00; TANGO INFINITY # (B)(6)