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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TG GPO-PAP TRIGLYCERIDES GPO

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ROCHE DIAGNOSTICS TG GPO-PAP TRIGLYCERIDES GPO Back to Search Results
Catalog Number 04657594190
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/09/2018
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer complained of discrepant results for 1 patient sample tested for trigl triglycerides (trigl) on a cobas c 111. The initial trigl result was 9. 50 mmol/l with a data flag. The sample was diluted 1:10 and repeated with a result of 3. 01 mmol/l. The sample was repeated neat and the result was 8. 97 mmol/l with no data flag. The result of 8. 97 mmol/l was reported outside of the laboratory. The sample was very lipemic so the high result was believed by the technician. On (b)(6) 2018 a new sample was obtained from the patient and the trigl result was 0. 76 mmol/l. Based on the lower result, the original sample was repeated and the result was 3. 23 mmol/l and the sample looked less lipemic. The patient was fasting when both samples were obtained. The customer is confident there was no sample mismatch. There was no allegation that an adverse event occurred. The c 111 serial number was (b)(4).
 
Manufacturer Narrative
The patient sample was submitted for investigation and tested on a c 111 with reagent lot 312720. The investigation received undiluted results of 3. 30 mmol/l with no data flag and 3. 42 mmol/l with no data flag. Qc results at the investigation site were within range. The customer's complaint could not be reproduced. The investigation was unable to find a definitive root cause.
 
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Brand NameTG GPO-PAP
Type of DeviceTRIGLYCERIDES GPO
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7841865
MDR Text Key119669184
Report Number1823260-2018-02947
Device Sequence Number1
Product Code CDT
Combination Product (y/n)N
PMA/PMN Number
K873049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04657594190
Device Lot Number31272001
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/04/2018 Patient Sequence Number: 1
Treatment
ARTERIA-VITA; CO-DAFALGAN; IRFEN; PANTAPRAZOLE; SEQUASE; VALACICLOVIR; ZOVIRAX CREME
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