MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer obtained questionable high test results for an unspecified number of patient samples using the phos2 phosphate (inorganic) ver.2 (phos2) assay on the cobas 6000 c (501) module (c501).The customer repeated a "few" patient samples to check for discrepancies and issued corrected reports.One example of erroneous patient data was provided.All results are in units of mg/dl, and all were released outside the laboratory.The initial result was 11.1.The sample was repeated on a second c501 analyzer with a result of 7.6, and on a third analyzer with a result of 7.7.The result of 7.6 was deemed correct and a corrected report was issued.No adverse event occurred.The phos2 reagent lot number is 22584501 with an expiration date of 07/31/2018.The field service representative adjusted the gear pump pressure, replaced reagent probes, and verified rinse mechanism levels.He performed a precision check that passed.The customer performed quality controls which passed.Investigation activities are ongoing.

Manufacturer Narrative

The root cause was the misadjusted gear pump, which led to reagent carryover and the discrepant results.The issue was resolved by the service activities.A general reagent issue could be excluded.

• Brand Name: COBAS 6000 C501 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: 6673279
• MDR Text Key: 78609503
• Report Number: 1823260-2017-01348
• Device Sequence Number: 0
• Product Code: CEO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• 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