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 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of low results for different assays, some with < test data flags on a cobas 6000 c (501) module.The customer provided erroneous results for 1 patient sample tested for lipc lipase colorimetric assay (lipc).The initial lipc result was 6.8 u/l with a data flag.This result was reported outside of the laboratory where the physician requested the sample be repeated based on the patient¿s history.The sample was repeated and the result was 199.4 u/l with a data flag.This result was also reported outside of the laboratory.There was no allegation that an adverse event occurred.The lipc reagent lot number and expiration date were not provided.The customer¿s liquid level detection and sample probe were checked and replaced.Based on the information available for investigation, an issue with the sample probe has been excluded.Alarms related to abnormal sample aspirations were observed during a review of the alarm trace.The results from the lipc test indicate an issue with sample volume.Taking these observations into consideration, a pre-analytic issue is suspected.

Manufacturer Narrative

After further investigation, it was determined that the event was due to an issue with the sample probe and not a pre-analytic issue as stated initially.Investigation has determined that in very rare cases, a disturbance of the sample liquid level detection (lld) may occur due to fretting corrosion on the sample probe connector.This occurred due to a production change for the connector.In those cases where the disturbance of the lld occurs, the affected sample probe may dip into the sample material deeper than intended, therefore the sample probe may be not washed adequately, which may lead to carryover.The affected sample probe connector type has been changed in production to a new connector type.With that new connector type, the lld is ensured to fully function as specified.A guide for identifying potentially affected sample probes is being provided to customers.The potentially affected sample probes will be exchanged free of charge to customers.In addition, a workaround for this issue is being provided to customers to implement until their new probes are received.

• 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: 6829654
• MDR Text Key: 83998268
• Report Number: 1823260-2017-01850
• Device Sequence Number: 0
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 10/05/2017

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: 08/10/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 10/05/2017
• 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
• Removal/Correction Number: 1823260-03/14/17-002-C
• Patient Sequence Number: 1
• Patient Age: 35 YR