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); Fluid/Blood Leak (1250)

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

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that an anti-fy(a) of a control reagent was missed when using biotest cell 1&2 on tango optimo.The customer reported that the control showed a positive result in the first runs on tango optimo, but during a re-testing the control yielded a false negative test result.The customer returned the supposedly defective product, the control that had caused a false negative test result and also the affected anti-human globulin anti-igg solidscreen ii for investigational testing.Upon arrival on our premises, the vial containing the supposedly defective product was completely leaked out.Therefore our quality control laboratory tested the control with their retained sample of biotest cell 1&2 on tango optimo.It showed a correct positive result with cell #1 of biotest cell 1&2.The retained sample of biotest cell 1&2 was also tested with different controls and samples, e.G.Anti-fy(a).All positive and negative reactions were correct.We did not observe any false negative reaction.Additionally the affected anti-human globulin anti-igg solidscreen ii provided by the customer was also tested and yielded correct results.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotest cell 1&2 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 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: 6331282
• MDR Text Key: 67855034
• Report Number: 9610824-2017-00007
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2017
• Device Catalogue Number: 816 014100
• Device Lot Number: 8650011-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: No
• 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: ANTI-IGG, LOT 8619210-02; TANGO OPTIMO, # 9142400460