MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

Catalog Number 816 014100

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456); Defective Device (2588)

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

Event Date 03/19/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that she missed an anti-s when using biotest cell 1 and 2 on tango infinity.The customer returned the supposedly defective product and also the patient sample which had caused a false negative test result for investigational testing.The customer also returned the affected anti-human globulin (ahg) anti-igg solidscreen ii and the affected low ionic strength solution (liss) mlb2.Therefore our quality control laboratory tested the patient sample on tango infinity with the reagents provided by the customer and yielded correct positive results.The supposedly defective product was also tested with different samples and controls, e.G.An anti-s.All positive and negative reactions were correct.We did not observe any false negative reaction during testing on tango infinity.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotest cell 1 and 2 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of both allegedly defective lots.The affected tango infinity was inspected by our field service engineers.A metrology check was performed according to manufacturer's checklist and the instrument was confirmed to run.Within the metrology testing, the solidscreen ii assay was performed with controls and yielded acceptable results.This incident does not meet our reporting criteria for instruments.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 1&2
• Type of Device: BIOTESTCELL 1&2
• 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 ; 103 3130 5
• MDR Report Key: 6502728
• MDR Text Key: 73459298
• Report Number: 9610824-2017-00028
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952380
• UDI-Public: 07611969952380
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 04/19/2017

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: 03/13/2017
• Device Catalogue Number: 816 014100
• Device Lot Number: 8703011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/19/2017
• 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
• Treatment: AHG, LOT 8608120-04 EXP. 08/19/2017; MLB 2, LOT 8624130-00, EXP. 06/06/2018; SOLIDSCREEN II STRIP, LOT 8610010 EXP. 04/03/2018; SOLIDSCREEN II STRIP, LOT 8615040 EXP. 04/08/2018; TANGO INFINITY, # 4230000105