MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL 3

Catalog Number	816085100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false negative reactions of biotestcell 3 when used with the control reagent of a competitor.The customer stated that they see false negative reactions with cell 3 of biotestcell 3 in the manual tube test.The customer could not provide the specificity of the control reagent, but only the information that it is supposed to react positively with cell 3 of biotestcell 3.The customer described this issue as being "ongoing" but aside of the stated date of event we received no information on the additional dates of event.For this reason, only this one mdr is filed.The customer returned the allegedly defective biotestcell 3 sample for investigational testing and the also affected anti-human globulin, but not the control reagent of the competitor.At the time we received the material sent in by the customer the supposedly defective product biotestcell 3 was already expired.But within its shelf life our quality control laboratory had manually tested their retention sample of the supposedly defective lot of biotestcell 3 with different controls and samples, e.G.Anti-c, anti-fy(a) and anti-fy(b).All positive and negative reactions were correct.We did not observe any false negative reaction.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Testing of the anti-human globulin provided by customer is still ongoing.
Event or Problem Description
The customer reported a false negative reaction of biotestcell 3 with the control reagent of a competitor.The customer stated that they see false negative reactions with cell 3 of biotestcell 3 in the manual tube test.The customer could not provide the specificity of the control reagent, but only the information that it is supposed to react positively with cell 3 of biotestcell 3.The customer returned the complaint sample biotestcell 3 for investigational testing and also the affected anti-human globulin, but not the control reagent of the competitor.At the time we received the customer's material the supposedly defective product biotestcell 3 was already expired.But within its shelf life our quality control laboratory had manually tested their retention sample of the supposedly defective biotestcell 3 lot with different controls and samples, e.G.Anti-c, anti-fy(a) and anti-fy(b).All positive and negative reactions were correct.We did not observe any false negative reaction.Additionally the rh phenotype and the k (kel1), s (mns3) and s (mns4) antigens of cell #3 were confirmed.Our quality control laboratory also tested the anti-human globulin (ahg) anti-igg provided by the customer.The potency testing was done in parallel with the retention sample and a reference lot.All three ahg reagents showed comparable results in potency.The section limitation of the instruction for use contains the following note: "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." testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell 3 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.We did not receive any further complaints related to this issue.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 3
• Common Device Name: BIOTESTCELL 3
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 9980795
• Report Number: 9610824-2020-00018
• Device Sequence Number: 19002466
• Product Code: QHT
• UDI-Device Identifier: 07611969952687
• UDI-Public: (01)07611969952687(17)200406(10)8007021-00
• 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): 05/19/2020

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: 04/06/2020
• Device Catalogue Number: 816085100
• Device Lot Number: 8007021-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/19/2020
• 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: AHG, LOT 8846130-03; AHG, LOT 8846130-03; MLB, LOT 8907200-00; MLB, LOT 8907200-00