MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IGG-2 TINA-QUANT IGG GEN.2; IGG, ANTIGEN

Catalog Number 03507432190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer received questionable igg-2 tina-quant igg gen.2 results for one patient sample from cobas 8000 c 502 module serial number (b)(4).The initial result was 9.3 mg/dl with a data flag and was reported outside the laboratory as <30 mg/dl.The repeat result with an increased sample volume was 888.4 mg/dl with a data flag.A second sample from the patient was tested and the result was 903 mg/dl.This result was reported outside the laboratory and was believed to be correct.The physician called and questioned the first result because he had expected the igg to be high and because the result on the second draw was reported out as the high value.The patient was not adversely affected.The customer refused a service visit and stated he did not believe there was a hardware issue.

Manufacturer Narrative

A specific root cause could not be identified.No sample material was available for further testing.The calibration trace did not show any issues.Interference due to a gammopathy was possible but unlikely as the igm result was in the normal range at 42 mg/dl.After further investigation, no general interference was suspected.The customer said that the sample was a short draw so it was poured off into a micro cup for testing.Numerous alarms were noted that indicate an issue with appropriate sample volumes in the cups.The event may have been caused by sample mispipetting due to gel particulates.The customer confirmed they have not had any issues with other samples or applications.

• Brand Name: IGG-2 TINA-QUANT IGG GEN.2
• Type of Device: IGG, ANTIGEN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6399309
• MDR Text Key: 69876811
• Report Number: 1823260-2017-00549
• Device Sequence Number: 1
• Product Code: DEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050113
• 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,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 03507432190
• Device Lot Number: 15077701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1