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 Consequences Or Impact To Patient (2199)
Date of Event	12/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
A customer reported a false negative antibody screening test with biotest cell 1&2 on tango infinity.The specificity of the missed antibody is anti-s.The customer returned the supposedly defective product and also the patient sample that had caused a false negative test result.Testing in our quality control laboratory is still ongoing.The affected tango optimo as well as the affected tango infinity were inspected by one of our field service engineers with no indication for an instrument or software malfunction.Both instruments were confirmed to operate within specification.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that a patient sample (prenatal, with an anti-s) yielded a false negative antibody test in both tango optimo and tango infinity when tested with biotestcell 1 & 2, # 8643021-00.The customer was able to detect the antibody in the tubetest with peg (heterozygous cell reacted 1+ and 2+, homozygous cell reacted 2+).The customer sent in the patient sample for investigational testing as well as a sample of the allegedly defective biotestcell lot and also the solidscreen ii ahg used in this false negative test.At the time the material arrived on our premises, the affected batch had already expired.The affected lot had already expired at the time the customer filed her complaint.Although the allegedly defective product sample was already expired, it was tested in our quality control laboratory on tango optimo and tango infinity and yielded on both instruments a negative reaction.An anti-s used in this test reacted correctly positive.The ahg returned by the customer was used for testing.When tested with reference batch biotestcell 1&2 # 867021-00 - that was within its shelf life - the patient sample showed a correct 1+ positive result on both instruments.The patient sample was also tested in tube test (immediately spin (rzt), liss 10 min 37 ° c and in liss-iat) and reacted negatively, also in the liss / coombs gel card the reaction was negative.Since the affected batch had already expired at the time of testing, the reason for this false negative reaction remains unclear.The complained was classified as undetermined.A review of the batch record documentation showed no irregularities that might have negatively affected the quality of the allegedly defective lot.The affected tango optimo as well as the affected tango infinity were inspected by one of our field service engineers with no indication for an instrument or software malfunction.Both instruments were confirmed to operate within specification.

• 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: 6249276
• Report Number: 9610824-2016-00097
• Device Sequence Number: 13704000
• Product Code: KSZ
• UDI-Device Identifier: 07611969952380
• UDI-Public: 07611969952380
• 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): 12/05/2017

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: 12/19/2016
• Device Catalogue Number: 816 014100
• Device Lot Number: 8643021-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 12/05/2017
• 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 8608120-08, EXP. 08/19/2017; BIOTESTCELL 1&2, LOT 8647021-00, EXP. 01/16/2017; MLB 2, LOT 8615110-00, EXP. 04/04/2018; SOLIDSCREEN II STRIP, LOT 8617040, EXP. 04/22/2018; TANGO INFINITY, # 4230000158; TANGO OPTIMO, # 9142400194