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

Model Number P612

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

The customer stopped the analyzer and manually washed the sample probe.The customer discovered the sample probe had a piece of gel on the surface.The investigation reviewed the system's alarm trace and found aspiration alarms.The investigation is ongoing.

Event Description

The initial reporter received questionable ca2 calcium gen.2, alb2 albumin gen.2, gluc3 glucose hk gen.3, and tp2 total protein gen.2 results for five patients tested on a cobas c 503 analytical unit.The patient's initial results were not reported outside the laboratory.The customer performed repeat testing with the samples.Sample 1 had an initial calcium result of 1.20 mmol/l.The repeat calcium result was 2.22 mmol/l.Sample 2 had an initial albumin result of 7.2 g/l.The repeat albumin result was 39.1 g/l.Sample 3 had initial results of calcium 1.18 mmol/l and glucose 2.69 mmol/l.The repeat results were calcium 2.24 mmol/l and glucose 9.9 mmol/l.Sample 4 had an initial total protein result of 30.8 g/l.The repeat total protein result was 66.2 g/l.Sample 5 had an initial calcium result of 1.01 mmol/l.The repeat calcium result was 2.14 mmol/l.The calcium, albumin, and glucose reagent lot numbers and expiration dates were requested but not provided.The total protein reagent lot number was 577235 with an expiration date requested but not provided.

Manufacturer Narrative

The investigation found the customer's cobas p 612 pre-analytical system had the minimum volume set to 100 ul and the patient's sample tube was sent from the p 612 pre-analytical system to the cobas pro c 503.The investigation found the patient's sample tube caused a clot and abnormal aspiration alarms in parallel.The minimum volume settings in the cobas p 612 pre-analytical system were reconfigured from 100 ul to 400 ul.The investigation found the cobas p 612 pre-analytical system performed as configured.It was confirmed the p 612 pre-analytical system and the cobas pro c 503 are running without any issues and reconfiguration.

• 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): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14014782
• MDR Text Key: 291626623
• Report Number: 1823260-2022-00957
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

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: 08484775001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 05/30/2022
• Supplement Dates FDA Received: 06/21/2022
• 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
• Patient Sequence Number: 1