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

Catalog Number	816014100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that a strong antibody screening result of sample was called negative when tested with biotestcell 1&2 on tango infinity.The customer reviewed the results and edited this result to positive.Another weak positive result (passively acquired anti-d; rhogam) was also called negative by the instrument.The customer did not edit this result.The customer returned three samples and also the supposedly defective product for investigational testing.At the time we received the customer's samples on our premises, the supposedly defective product was already expired.Therefore our quality control laboratory tested the samples with their retention sample of the current lot of biotestcell 1&2 (lot 8815011-00) on tango infinity.All three samples yielded positive results.The retention sample of the supposedly defective biotestcell 1&2 lot was tested with different samples and controls on tango infinity within its shelf life and reacted as expected.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell 1&2 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of both allegedly defective lots.The affected tango infinity was inspected.Evaluation of the data is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that a strong antibody screening result of sample was called negative when tested with biotestcell 1&2 on tango infinity.The customer reviewed the results and edited this result to positive.Another weak positive result (passively acquired anti-d; rhogam) was also called negative by the instrument.The customer did not edit this result.The customer returned three samples and also the supposedly defective product for investigational testing.At the time we received the customer's samples on our premises, the supposedly defective product was already expired.Therefore our quality control laboratory tested the samples with their retention sample of the current lot of biotestcell 1&2 (lot 8815011-00) on tango infinity.All three samples yielded positive results.The retention sample of the supposedly defective biotestcell 1&2 lot was tested with different samples and controls on tango infinity within its shelf life and reacted as expected.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell 1&2 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of both allegedly defective lots.The affected tango infinity was inspected by our field service engineers and confirmed to operate within specification.As to the database and metrology certificate, no problems with ssc ii quality control testing occurred on the days of issue and during fse visit.It is likely that the reported problem is related to sample specificities, because one sample contained cold agglutinin and the other passive anti-d considering a weak antibody within this sample, which may be consequently close to the detection limit of the solidscreen ii method.

• 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, hessen 63303 ; GM 63303
• MDR Report Key: 7548158
• Report Number: 9610824-2018-00024
• Device Sequence Number: 1424763
• Product Code: KSZ
• UDI-Device Identifier: 07611969952380
• UDI-Public: (01)07611969952380(17)180507(10)8811021-00
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: 05/07/2018
• Device Catalogue Number: 816014100
• Device Lot Number: 8811021-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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, # 4230000189; TANGO INFINITY, # 4230000189