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

Model Number C501

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for four patient samples tested for ca2 calcium gen.2 (ca) on a cobas 6000 c (501) module - c501.All initial erroneous results were reported outside of the laboratory and corrected reports were issued for the repeat values.The first sample initially resulted as 1.95 mmol/l and repeated as 2.40 mmol/l.The second sample initially resulted as 1.89 mmol/l and repeated as 2.51 mmol/l.The third sample initially resulted as 1.90 mmol/l and repeated as 2.57 mmol/l.The fourth sample initially resulted as 1.97 mmol/l and repeated as 2.30 mmol/l.The customer provided the following additional values from the 4 patient samples: 1.93 mmol/l, 1.85 mmol/l, 1.88 mmol/l, and 1.82 mmol/l.It was asked, but it is not known from which sample each result was obtained, if these additional values are additional repeat results, or if these values replaced values that were already provided.No adverse events were alleged to have occurred with the patients.The ca reagent lot number was 223264.The reagent expiration date was asked for, but not provided.The customer resumed testing and stated that controls went back to normal.The customer monitored controls every 2 hours and saw no further issues after approximately 1 week.The field service engineer checked sampling and the probe.He checked the rinse mechanism and pipetting; all were ok.He could not detect any issues with the analyzer.The customer has confirmed that there have been no additional issues.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.

• 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: 6498257
• MDR Text Key: 72955556
• Report Number: 1823260-2017-00798
• Device Sequence Number: 0
• Product Code: CIC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• 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
• Date Manufacturer Received: 03/31/2017
• 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