MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C111; CLINICAL CHEMISTRY ANALYZER

Model Number C111

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained that the sodium results for ise indirect na, k, ci for gen 2 results from their cobas c 111 are not correlating with the sodium results from their istat.The customer stated that they started getting discrepant results dating back to (b)(6) 2017.The customer provided the sodium, potassium, and chloride data for 71 patients.Of the data provided there is a reportable malfunction for 13 different patient¿s sodium results and 1 patient¿s sodium, potassium, and chloride result.The repeat testing was performed on an istat.The repeat testing is deemed to be correct.The initial patient data was not reported outside of the laboratory.There were no adverse events.The lot numbers and expiration dates for the sodium, potassium, and chloride electrodes were requested but not provided.A field engineering specialist has visited the customer site on multiple occasions.He has replaced multiple parts, multiple consumables, performed numerous mechanical checks, and has replaced the entire ion selective electrode unit.Following service visits the customer would perform calibration and qc all of which would pass.The customer states that the sodium results are still constantly running lower on the cobas c 111 compared to the istat.The investigation is still ongoing.

Manufacturer Narrative

Service determined the issue is related to differences in methodology (direct vs.Indirect).All follow up testing and diagnostic checks performed passed with no further issues.The instrument is performing within specifications.It was recommended to the customer that they adhere to the centrifuge times for samples and to the maintenance schedule of the analyzer.The sodium electrode lot number is 21571527 with an expiration date that was requested but not provided.The potassium electrode lot number is 21571247 with an expiration date that was requested but not provided.The chloride electrode lot number is 21571247 with an expiration date that was requested but not provided.Customer clarified that "sample (b)(6)" matches the patient information from the initial medwatch.This event appears to be isolated in nature with no indication of a systemic failure of a roche product.The customer had had no similar complaints in the previous 12 months and the affected service part showed no abnormal trend over the past 90 days.

Manufacturer Narrative

In supplemental (b)(4) it was stated "the customer had no similar complaints in the previous 12 months.The original investigation statement was updated and the statement should read "the customer has had a similar complaint in the previous 12 months but this resolution is sustainable per escalation support engineer.The affected service part showed no abnormal trend over the past 90 days.".

Manufacturer Narrative

Besides the possible root cause scenario that was already mentioned in a previous supplemental report, further investigation determined another possible scenario.The chloride results recovered in the opposite direction from the sodium and potassium results.That means for example that if during the initial testing the chloride results were high while the sodium and potassium results were low, the repeat testing result for the chloride would then be low while the sodium and potassium results would then be high.Typical causes for this type of behavior include air in the sample channel, leakage current coming from the waste, or an old and/or expired reference electrode.As detailed pre-analytical information could not be provided pre-analytical factors could not be excluded.

• Brand Name: COBAS C111
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6844311
• MDR Text Key: 85094559
• Report Number: 1823260-2017-01900
• Device Sequence Number: 0
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071211
• 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,Followup,Followup
• Report Date: 11/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C111
• Device Catalogue Number: 04777433001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• 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
• Patient Age: 85 YR