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

Catalog Number	816014100
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	09/19/2021
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 that a patient sample showed a positive antibody screening test with biotestcell 1&2 on tango infinity.On further investigation the customer was able to identify an anti-cw.They used biotestcell-i11 plus and panel cells from immucor for the antibody identification.The customer was concerned because both cells of the affected biotestcell 1&2 lot were cw negative according to the provided antigen table.Based on their test results the customer suspected a typing error in the antigen table or a mistyping of the affected lot biotestcell 1&2.The customer did not return the affected product biotestcell 1&2 or the patient sample for investigational testing.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot.Both affected screening cells were tested with seraclone anti-cw.Both showed negative results.Additionally, the retention sample of biotestcell 1&2 was tested with an anti-cw (igg type) on tango infinity.Again, both screening cells showed completely negative results.The antigens of both donors had been tested, among others the cw antigen in the double determination.Both donors showed negative results.Within the final serological control of the supposedly defective lot the rh antigens were also tested.All tests confirmed that both donors were cw negative.The information in the antigen table were correct.Result images and log files of the affected tango infinity were not provided for investigation.The last preventive maintenance was conducted on april14, 2021.A field service engineer was not on-site because thsi complaint is not related to a technical issue.The customer was supported by phone call.Based on the investigation the complaint was classified as unjustified.All tests confirmed that the cw antigen is negative in both donors.The information in the antigen table provided was correct.A typo in the antigen table respectively a mistyping of both donors as suspected by customer could be excluded.We were unable to provide information on the specificity of the identified antibody because the sample was not made available to us.The customer did not provide all requested information but informed us that the complaint could be closed.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.From instrument's perspective, based on current information there is no indication for an instrument malfunction.

• 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: 12605635
• Report Number: 9610824-2021-00066
• Device Sequence Number: 20187022
• Product Code: QHT
• UDI-Device Identifier: 07611969952380
• UDI-Public: (01)07611969952380(17)210927(10)9130011-00
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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: 09/27/2021
• Device Catalogue Number: 816014100
• Device Lot Number: 9130011-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/11/2021
• 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: TANGO INFINITY, SN (B)(4)