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

Catalog Number	816 014100
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 about false negative antibody screening result for anti-k when using biotestcell 1&2 on tango infinity.The patient was tested at another facility and the patient sample was a known positive.The customer announced to send in samples for investigational testing.The investigation of the affected tango infinity by our field service engineers is still ongoing.Our quality control laboratory tested their retention sample of biotestcell 1&2 (ref (b)(4), lot 8015011-00) with two different anti-k reagents.The kell positive cell #1 of biotestcell 1&2 yielded a correctly positive result with both reagents.Our quality control laboratory is still waiting for the patient sample that caused the false negative result.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 1&2 (ref 816014100, 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 1&2 (ref 816065100, lot 8015011-00) with seraclone anti-k in the tube test with an incubation for 5 minutes at room temparature and with a polyclonal anti-k in the indirect antiglobulin test (iat).Cell #1 (donor #(b)(6), k+k+) of biotestcell 1&2 yielded a correctly positive result in both tests.The customer did not provide result images or the log files for analysing the instrument'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 is running within specification.Because the complaint sample was not available for investigation, the retention sample reacted as expected and the patient sample in question has not been provided, the root cause of the false negative result at the 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 1&2
• Common Device Name: BIOTESTCELL 1&2
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 10205434
• Report Number: 9610824-2020-00041
• Device Sequence Number: 3298603
• Product Code: QHT
• UDI-Device Identifier: 07611969952380
• UDI-Public: (01)07611969952380(17)200806(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): 09/02/2020

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: 816 014100
• 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: 06/29/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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 POOL, LOT 8015011-00; BIOTESTCELL POOL, LOT 8015011-00; IH-1000 SN (B)(6) ; IH-1000 SN 51000035; TANGO INFINITY, # 4230000149; TANGO INFINITY, # 4230000149