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

Model Number P612

Device Problem High Test Results (2457)

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

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received a questionable high crep2 creatinine plus ver.2 result for one sample from a patient.The customer had three serum tubes drawn from the patient which were labeled with two different samples ids.All three samples were processed via the pvt (p471/p612) preanalytic system and two of the samples were tested on cobas 8000 c (701) module serial number (b)(4).One sample with (b)(6) (sample b) had a creatinine result of 314 umol/l and the sample with (b)(6) (sample c) had a result of 177 umol/l.Both results were reported outside of the laboratory and were questioned by the physician.There was no allegation of an adverse event.The creatinine reagent lot number was 283369.The expiration date was requested but was not provided the laboratory checked the labeling of the tubes, all other results for the samples, and the blood type of the samples.The customer was certain both of these samples were from the same patient.On (b)(6) 2017 the laboratory retested all three samples with both crep2 creatinine plus ver.2 and creatinine jaffe methods as part of troubleshooting.The results showed the same discrepancy for the one suspect sample tube (sample b).The customer suspected the sample tube had been contaminated.The field service representative checked the instrument and performed minor adjustments.Afterward, the instrument performed within specification.Review of the provided reaction data confirmed the contamination and excluded interference from the patient's myeloma.As no other analytes were affected, a general patient or analyzer issue was not suspected.As only one of the samples was affected, an interference with the patient's medication or sample probe carry over could be excluded.The source of the contamination was unknown, but was likely the pvt (p471/p612) preanalytic system.

Manufacturer Narrative

Further investigation ruled out contamination and was unable to find a definitive root cause.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• 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: 7117014
• MDR Text Key: 95741521
• Report Number: 1823260-2017-02921
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• 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: 02/19/2018

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 11/27/2017
• Supplement Dates FDA Received: 02/19/2018
• 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: 80 YR