MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL I11 PLUS

Catalog Number	816022100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2017
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 that one patient sample with an anti-jk(a) showed false negative reactions with biotest cell-i11 plus when tested on tango infinity.The customer reported that the anti-e of the affected sample was correctly detected.She stated that during validation antibodies of overall four samples were not detected on tango infinity.The specificities of the missed antibodies were anti-jk(a) and anti-fy(a).The customer returned one sample that had caused false negative test results and also the supposedly defective product biotest cell-i11 plus.The specificity of the submitted sample was anti-fy(a).Our quality control laboratory tested this specimen with the sample of biotest cell-i11 plus returned by the customer on tango infinity.The anti-fy(a) was clearly detected.The complaint sample was also tested with different samples and controls on tango infinity, e.G.An anti-e, anti-jk(a) and anti-fy(a).All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotest cell-11 plus functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL I11 PLUS
• Common Device Name: BIOTESTCELL I11 PLUS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6617153
• Report Number: 9610824-2017-00038
• Device Sequence Number: 926445
• Product Code: KSZ
• UDI-Device Identifier: 07611969952441
• UDI-Public: (01)07611969952441(17)170605(10)8715011-00
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 06/07/2017

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: 06/05/2017
• Device Catalogue Number: 816022100
• Device Lot Number: 8715011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1