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	06/13/2017
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 patient sample with anti-d showed a false negative reaction with cell #4 of biotest cell-i11 plus.The customer performed the manual tube testing with the enhancement of polyethylene glycol (peg).The customer was not able to provide a date of event.The customer returned the patient sample that had caused a false negative test result and also the supposedly defective product for investigational testing.Testing in our quality control laboratory is still ongoing.Additionally our quality control laboratory tested the complaint sample in parallel to the retention sample with different samples and controls including anti-d.All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed that the 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.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that a patient sample with anti-d showed a false negative reaction with cell #4 of biotestcell-i11 plus.The customer performed the manual tube testing with the enhancement of polyethylen glycol (peg).The customer returned the patient sample that had caused false negative results and also the supposedly defective product biotestcell-i11 plus for investigational testing.Our quality control laboratory tested the allegedly defective sample in parallel to their retain sample with different samples and controls including anti-d.All positive and negative reactions were correct.We did not observe any false negative reaction.The antigenicity of cell#4 was not weakened.Additional testing of the provided sample by quality control confirmed that the patient does not have an anti-d but we found a weak anti-c when testing with enzyme treated cells.Testing by our quality control laboratory confirmed the correct functionality of the allegedly defective lot biotestcell-11 plus.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.In the menatime the customer called to say that an handling error happened when they performed their testing of the samples.

• 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: 6709794
• Report Number: 9610824-2017-00045
• Device Sequence Number: 16478483
• Product Code: KSZ
• UDI-Device Identifier: 07611969952441
• UDI-Public: (01)07611969952441(17)170703(10)8719011-00
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/17/2017

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: 07/03/2017
• Device Catalogue Number: 816022100
• Device Lot Number: 8719011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1