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 Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer received a questionable lipc lipase colorimetric assay result for one patient sample.The sample in question was hemolyzed and the lipase result was 228 u/l.This result was reported outside the laboratory and was questioned by the physician who said the result did not correlate to the clinical situation for the patient.A new sample was drawn from the patient on (b)(6) 2017 and the lipase result was 38 u/l.A new sample was drawn from the patient on (b)(6) 2017 and the lipase result was 21 u/l.These samples were not hemolyzed.There was no allegation of an adverse event.The reagent lot number was 247189.The expiration date was requested but was not provided.The customer thinks the erroneous high lipase result may have been due to the hemolysis of the sample.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The effect of hemolysis on the result was ruled out based on the data provided.As calibration and qc was within range, a reagent or instrument problem could be excluded.Most likely, there was another sample specific issue or carry-over which caused the issue.

• 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: 6681540
• MDR Text Key: 79150470
• Report Number: 1823260-2017-01387
• Device Sequence Number: 0
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/18/2017

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: 06/19/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 06/19/2017
• Supplement Dates FDA Received: 08/18/2017
• 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