MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of an erroneous high result for 1 patient tested for lipc lipase colorimetric assay (lipc).It is not known if the erroneous result was reported outside of the laboratory.The initial lipc result from a cobas 6000 c (501) module was 129.1 u/l.This result was an aliquot sample from the customer¿s modular pre-analytic (mpa) system.Since all other patient test results were normal, the sample from the primary tube was repeated on (b)(6) 2017 and the result was 21.0 u/l.To confirm this, a secondary tube that had been drawn at the same time as the primary tube was repeated twice on the c501 module and the results were 19.7 u/l and 25.0 u/l.No adverse event occurred.The lipc reagent lot number was 179823 with an expiration date of 09/30/2017.The customer stated that this issue was only observed for this one patient.

Manufacturer Narrative

Calibration and quality control (qc) data were acceptable.The discrepant lipc results were from the same analyzer and only for 1 patient.A specific root cause was not identified.Additional information was requested for investigation but was not provided.Since calibration and qc data were acceptable and since the issue occurred only once, both a general reagent issue and hardware issue have been excluded.Since the assumed correct result was confirmed by repeating the sample from the primary tube and by repeating a sample from a secondary tube drawn at the same time as the primary tube twice, the most likely root cause is a preanalytical issue.Either too much sample was transferred via the sample probe (through deposits on the outside) or debris caused an artificial signal, however, since the reaction monitors are no longer available, this cannot be verified.

• Brand Name: COBAS 6000 C (501) MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6368695
• MDR Text Key: 68781419
• Report Number: 1823260-2017-00436
• Device Sequence Number: 0
• Product Code: CHI
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: 02/06/2017
• Supplement Dates FDA Received: 07/10/2017
• 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: N
• Patient Sequence Number: 1