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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS IGG-2 TINA-QUANT IGG GEN.2 IGG, ANTIGEN Back to Search Results
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.
 
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Brand NameIGG-2 TINA-QUANT IGG GEN.2
Type of DeviceIGG, 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 Key6399309
MDR Text Key69876811
Report Number1823260-2017-00549
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue Number03507432190
Device Lot Number15077701
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2017
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

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