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	10/05/2020
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 they used biotestcell 1&2 (ref #816014100, lot #8035011-00) in the tube test and did not pickup an anti-d.The customer stated that they used the tube test for both qc and patient samples with a passive anti-d.He also stated that the anti-d was picked up when the reagent was used on their ih-500.The customer used ih basic qc as control (qc).The customer did neither provide the complaint sample for investigational testing nor the patient samples that caused the false negative test result and he also provided a table with their test results.Our quality control laboratory tested their retention sample of the anti-human globulin (ahg) anti-igg lot 8846130-05 used by the customer for potency.The testing was done in parallel to a reference lot (lot #8948030-05).Both lots met the acceptance criterion.The retention sample of biotestcell 1&2 was tested for specificity in the tube method (30 minutes indirect antiglobulin test (iat).All positive and negative reactions were correct.Additionally the d antigenicity of the retention sample of biotestcell 1&2 lot #8035011-00 was tested.Again, the acceptance criteria were met.We did not observe any weakened d antigenicity of the reagent red blood cells.We would like to point out, that the intended use of ih-basic qc is the ih-system and not the tube test.In the instruction for use of the ih-basic qc the concentration of the anti-d was given: 0.05 iu/ml.According to our experience the tube test is not sensitive enough to detect this low concentration, in contrast to the ih gel method.The false negative reactions of the passive anti-d samples remained unknown, because the samples were not available for investigation.But we would like to note that the chapter limitations contains the following part: "negative reactions will be obtained if the sample contains antibodies present in concentrations too low to be detected by the test method employed.No test method is capable of detecting all red cell antibodies.

• 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: 10769892
• Report Number: 9610824-2020-00076
• Device Sequence Number: 1902267
• Product Code: QHT
• UDI-Device Identifier: 07611969952380
• UDI-Public: (01)07611969952380(17)201026(10)8035011-00
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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: 10/26/2020
• Device Catalogue Number: 816 014100
• Device Lot Number: 8035011-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1