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

Model Number C501

Device Problems Incorrect Or Inadequate Test Results (2456); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer questioned results for 1 patient sample tested for ise indirect na, k, ci for gen.2 on a cobas 6000 c (501) module.Based on the data provided, the k and cl results are a reportable malfunction.The initial k result was 8.18 mmol/l.The initial cl result was 69.7 mmol/l.The customer repeated the sample and the k result was 320.16 mmol/l with a data flag and the cl result was 1.7 mmol/l with a data flag.These results were not believable.No erroneous results were reported outside of the laboratory.The customer replaced the ise reagents and all electrodes; during this, the customer found the bottle of internal standard reagent was almost empty.An ise check was performed after priming the internal standard reagent.Ise checks were within range.The customer re-calibrated and ran qc.Afterwards, the customer repeated the patient sample and the k result was 4.50 mmol/l and the cl result was 99.3 mmol/l.These results were believed to be correct.No adverse event occurred.No electrode lot numbers or expiration dates were provided.The field service engineer (fse) visited the customer site and confirmed the instrument was operating according to specification.

Manufacturer Narrative

The new component code, new evaluation method code, new evaluation result code and new evaluation conclusion code have been updated.

• Brand Name: COBAS 6000 C501 MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7664041
• MDR Text Key: 113508744
• Report Number: 1823260-2018-02208
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR