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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial final report on this incident.
Event or Problem Description
The customer reported a presumably false negative antibody screening test with biotestcell 1&2 on tango infinity.The specificity of the missed antibody is anti-s.The customer did not return the supposedly defective product for investigational testing but the patient sample that had caused a false negative test result.Testing in our quality control laboratory is still ongoing.The two affected tango infinity were inspected by our field service engineers.Evaluation of the data is ongoing.
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, # 8647021-00.The customer was able to detect the antibody in the tube with peg (heterozygous cell reacted 1+ and 2+, homozygous cell reacted 2+).The customer sent in the patient sample for investigational testing and biotestcell 1&2, # 8643021-00, that was already expired, but not the complained material biotestcell 1&2, # 8647021-00.The solidscreen ii ahg, that was used as the complaint occurred, was also sent in.Our quality control laboratory tested their retained sample of biotestcell 1&2 # 8647021-00.The patient sample showed a correct 1+ positive result with rrbc 2 on both instruments.The soldiscreen ii ahg returned by the customer was used for this testing.The patient sample was also tested in the 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.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 that might have negatively affected the quality of the allegedly defective lot.The two affected tango infinity were inspected by our field service engineers with no indication for an instrument or software malfunction.Both instruments were confirmed to operate within specifications.

• 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: 6249168
• Report Number: 9610824-2016-00096
• Device Sequence Number: 13660661
• 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: 01/16/2017
• Device Catalogue Number: 816 014100
• Device Lot Number: 8647021-00
• Was Device Available for Evaluation?: No
• 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 8643021-00; MLB 2, LOT 8615110-00, EXP. 04/04/2018; SOLIDSCREEN II STRIP, LOT 8617040, EXP. 04/22/2018; TANGO INFINITY, # 4230000158; TANGO OPTIMO, # 9142400194