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

Catalog Number	816021100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2019
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 a false negative result on her tango infinity when using biotestcell-i11.The customer stated that within her validation of her new tango infinity a sample (#922062) with an anti-c and anti-e showed false negative results with biotestcell-i11.The sample yielded weak positive reactions in the gel method of a competitor.But not all c (rh2) and e (rh5) positive reagents red blood cells that were supposed to yield positive reactions due to the antigen pattern showed positive reactions.The customer did neither return the supposedly defective product for investigational testing nor the sample that had caused the false negative test result.At the time we recorded this complaint the supposedly defective product was already expired.Therefore a testing of the retention sample of the complained lot was not performed by our quality control labaratory.The delayed recording of this complaint is processed within our deviation system.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.Regarding the affected tango infinity: result images from available samples were reviewed (sourced from sent database validate.Phb = lab journal).The images from complaint samples are showing negative results, which can be visually confirmed as negative.The instrument was inspected by one of our field service engineers and log files collected.Metrology was run and verified that all were within manufacturer ranges.Metrology qualification was performed with passing qc.The antibodies were originally detected in ortho gel and some samples were repeated in gel after infinity testing.The log files did not show any issue relevant abnormalities.The control database did not contain any weakening solidscreen ii qc.No indication for an instrument malfunction could be identified on current data.The service engineer confirmed a proper function of the instrument.As to database, no problems with quality control testing on solidscreen ii method on the days of issue occurred.The control samples did pass every day.The reported problem is likely related to sample specificities.The antibodies within affected sample may have been present in too low concentration (boarderline) to be evaluated as positive reaction by the solidscreen ii method.The usage of different methods may result in different results for weak reacting antibodies and the methods have different detection specifications.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL-I11
• Common Device Name: BIOTESTCELL-I11
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 9303798
• Report Number: 9610824-2019-00060
• Device Sequence Number: 19321111
• Product Code: KSZ
• UDI-Device Identifier: 07611969952434
• UDI-Public: (01)07611969952434(17)191007(10)8933011-00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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: 07/10/2019
• Device Catalogue Number: 816021100
• Device Lot Number: 8933011-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1