MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 612 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM

Model Number P612

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer questioned ise indirect na, k, ci for gen.2, ca2 calcium gen.2, and elecsys tsh assay results for a patient sample aliquot processed by the cobas p 612 pre-analytical system (mpa) that was tested on multiple analyzers.Of the data provided the k results from cobas 8000 ise module and ca from the cobas 8000 c (701) module were erroneous.This medwatch will cover the mpa.Refer to medwatch with (b)(6) for information on the erroneous results from the c701 module and medwatch with (b)(6) for information on the erroneous results from the ise module.The erroneous results were not reported outside the laboratory and there was no adverse event.The initial results were from an aliquot processed by the mpa and the repeat results were from a new aliquot of the original sample tube.The initial k result was 3.6 mmol/l and the repeat result was 4.9 mmol/l tested on the ise module.The initial ca result was 7.1 mg/dl and the repeat result was 10.4 mg/dl tested on the c701 module.The customer stated that different sample tube from the same draw was tested and did not "match".The customer did not provide the results and stated that there was an issue with the tube.The k electrode lot number and expiration date was requested but not provided.The ca reagent lot number and expiration date was requested but not provided.The field service engineer (fse) ran all fluid, ran all dispense checks, observed tubing, and observed syringe operation.All were acceptable.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The investigation determined the issue have happened during sample transportation.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• 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: 7041602
• MDR Text Key: 93339926
• Report Number: 1823260-2017-02652
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P612
• Device Catalogue Number: 05082579001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 12/28/2017
• 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