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

Catalog Number 816022100

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

This is our combined initial and final report on this incident.

Event Description

The customer reported a false negative reaction of a patient sample with a known anti-d with cell #4 of biotest cell-i11 plus on tango optimo.The customer returned the supposedly defective product biotest cell-i11 plus, but only the affected cell #4 and not the complete panel.The customer also returned the patient sample that had caused a false negative test result.At the time we received the material provided by customer the supposedly defective product was already expired.Nevertheless our quality control laboratory tested the patient sample with the complaint sample on tango optimo and yielded a correctly positive result.Additionally the patient sample was tested with the current lot of biotest cell-i11 plus.All positive and negative reactions were correct.We did not observe any false negative reaction.The retention sample of the complained lot was tested during its shelf life with different samples and controls e.G.Anti-d.Again, all results were as expected.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotest cell-i11 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.The affected tango optimo was inspected by our field service engineers with no indication for an instrument malfunction.The service engineer confirmed a proper function of the instrument by metrology qualification.Also the ssc ii qc of other testing days was run without any complaint relevant issue.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL I11 PLUS
• Type of Device: BIOTESTCELL I11 PLUS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7036865
• MDR Text Key: 93368938
• Report Number: 9610824-2017-00092
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952441
• UDI-Public: (01)07611969952441
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2017
• Device Catalogue Number: 816022100
• Device Lot Number: 8735011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1