MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C702

Device Problem Low Test Results (2458)

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

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of low gluc3 glucose hk gen.3 results for 2 patient samples run on the cobas 8000 c 702 module.The results for both patient samples are a reportable malfunction.The glucose results the units were not provided.Patient #1 had an initial glucose result of 0.00.The sample was repeated on another analyzer and a result of 4.41 was obtained.Patient # 2 had an initial glucose result of 0.02.The sample was repeated on another analyzer and a result of 6.94 was obtained.For both patients the initial glucose results were reported outside of the laboratory.The ordering department questioned the initial glucose results as they considered them unbelievable.The repeat results were deemed to be correct.There was no allegation of an adverse event.The customer checked the initial analyzer and found no data or instrument alarms.Further investigation of the reaction monitors for the initial results showed that there was no sample added to the reaction cell pointing towards a sample aspiration error.The customer does not believe a contamination of the samples is likely as they manually pipetted the samples into false bottom tubes that were loaded into the appropriate sample rack type.The glucose reagent lot was 242156 with an expiration date that was not provided.The investigation is currently ongoing.

Manufacturer Narrative

Further investigation confirmed that the sample probes were not contaminated.The issue was mostly likely caused by a sample pipetting error but the specific root cause cannot be identified.The issue did not recur.

• Brand Name: COBAS 8000 C 702 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: 6939567
• MDR Text Key: 90182569
• Report Number: 1823260-2017-02250
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K100853
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C702
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• 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