MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LIPC LIPASE COLORIMETRIC; LIPASE TEST SYSTEM

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer questioned high results for 1 patient tested for lipase on a cobas 6000 c (501) module.The patient had been tested for lipase on the c501 module initially with a result of 739 u/l.The sample was repeated on "another system" and the result was 733 u/l.On (b)(6) 2018 the patient was tested on the c501 module with a result of 981 u/l.This result was reported outside of the laboratory.The sample was sent to an external laboratory using the abbott method and the result was 150 u/l.The date of the event is either (b)(6) 2018.Clarification on this has been requested but not provided.There was no allegation that an adverse event occurred.The c501 module serial (b)(4).The customer suspects an interference in the sample affecting the results.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

It was clarified that the date of event was (b)(6) 2018.

Manufacturer Narrative

There were no system issues at the time of the event and maintenance was up to date.

Manufacturer Narrative

The following is a correct timeline of the event: on (b)(6) 2018 the patient was tested on the c501 module with a lipase result of 981 u/l with a data flag.This result was reported outside of the laboratory.The sample from (b)(6) 2018 was sent to an external laboratory using the abbott method and the result was 150 u/l.On (b)(6) 2018 the patient was tested for lipase on "another system" and the result was 594 u/l with a data flag.The sample was repeated using reduced mode and the result was 733 u/l.On (b)(6) 2018 the patient was tested on the c501 module and the result was 739 u/l with a data flag.The sample was repeated using reduced mode and the result was 733 u/l.Calibration and qc results were acceptable.An abnormal sample aspiration alarm was observed on the alarm trace from (b)(6) 2018.The customer is not having issues with any other assays.

• Brand Name: LIPC LIPASE COLORIMETRIC
• Type of Device: LIPASE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7751778
• MDR Text Key: 116865174
• Report Number: 1823260-2018-02615
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): N
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 07/19/2018; 07/19/2018; 07/19/2018; 07/19/2018
• Supplement Dates FDA Received: 08/10/2018; 09/04/2018; 09/24/2018; 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR