MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P612; PREANALYTICAL SYSTEM

Model Number P612

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

The customer uses sarstedt sample tubes.The sample tubes are collected offsite, transported by a car to the laboratory, centrifuged, and then placed in the bulk loader.The field service representative stated that he observed samples generating bubbles when the bulk loader of the p612 system arranges the sample on the conveyor.The investigation reviewed the customer's calibration and qc results and the results were within the acceptable ranges.The investigation reviewed the system's alarm trace and found multiple alarms related to sample quality issues.The customer provided the sample foam detection camera images from the e 801 module.The investigation determined the questionable results were caused by the sample quality.The sample had a film across the surface in all of the images provided.There was no indication for a general reagent or e 801 module issue.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys vitamin b12 immunoassay, elecsys ferritin, elecsys ft4 iii assay, elecsys insulin, elecsys vitamin d total ii results for one patient initially processed by a cobas p612 preanalytical system and tested on a cobas 8000 e 801 module.The patient's initial results were reported outside the laboratory.The customer performed repeat testing with the patient's sample.The patient's initial results were vitamin b12 100 pg/ml with a data flag, ferritin 12.9 ng/ml, ft4 0.343 ng/dl, insulin 0.549 uu/ml, and vitamin d 100 ng/ml with a data flag.The patient's repeat results were vitamin b12 650 pg/ml, ferritin 234 ng/ml, ft4 1.23 ng/dl, insulin 9.54 uu/ml, and vitamin d 54.9 ng/ml.The serial number for the e 801 module was (b)(4).The vitamin b12 reagent lot number was 584567 with an expiration date requested but not provided.The ferritin reagent lot number was 571811 with an expiration date requested but not provided.The ft4 reagent lot number was 572941 with an expiration date requested but not provided.The insulin reagent lot number was 584531 with an expiration date requested but not provided.The vitamin d reagent lot number was 570755 with an expiration date requested but not provided.

Manufacturer Narrative

The investigation advised the customer to use the bulk loader of the p612 system for uncentrifuged samples or to skip the use of the bulk loader for already centrifuged samples.The customer refused the recommendation.Based on the provided information, the investigation determined the event was consistent with a sample pre-analytic handling issue.

• Brand Name: COBAS P612
• Type of Device: 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: 13668567
• MDR Text Key: 286589099
• Report Number: 1823260-2022-00575
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/21/2022

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: 07962703001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/21/2022
• 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
• Patient Age: 23 YR
• Patient Sex: Female