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
• UDI-Device Identifier: 04015630921959
• UDI-Public: 4015630921959
• 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: Health Professional
• Device Catalogue Number: 04657594190
• Device Lot Number: 31272001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTERIA-VITA; CO-DAFALGAN; IRFEN; PANTAPRAZOLE; SEQUASE; VALACICLOVIR; ZOVIRAX CREME
• Patient Age: 66 YR