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

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.

• Brand Name: TG GPO-PAP
• Type of Device: TRIGLYCERIDES GPO
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7841865
• MDR Text Key: 119669184
• Report Number: 1823260-2018-02947
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): N
• PMA/PMN Number: K873049
• Number of Events Reported: 1
• 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 Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04657594190
• Device Lot Number: 31272001
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2018
• 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