MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 512 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM

Model Number P 512

Device Problems Incorrect Measurement (1383); Contamination /Decontamination Problem (2895)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e801 module serial number was (b)(6).The hcg+b reagent lot number was 732240 with an expiration date of 31-oct-2024.The investigation is ongoing.

Event Description

The initial reporter complained of an issue with a cobas p512 pre-analytical system.The customer repeated 250 patient samples with elecsys hcg+b (hcg + b) results of < 10 iu/l from the p512 system.During the run on (b)(6) 2023, discrepant results were identified for 1 patient.The initial result was < 0.200 iu/l with a data flag.The repeated results were 14.1 iu/l, 14.4 iu/l, and 14.47 iu/l.Based on these results, the customer alleges cross-contamination occurred.

Manufacturer Narrative

The primary tube transporter (ptt) of the output sorter shows fallen tubes and loose sealing foils.It was noted that an incorrect open group was activated in the system.The decapper unit had tape around the upper edge of the waste funnel; this indicates use outside of specifications.A loose gray cap was also observed.The customer uses a manual pre-analytic workflow allowing for multiple possibilities for contamination.These possibilities could be avoided by using an automated pre-analytic workflow for which the customer has instrumentation installed but is not using.Manual blood drawing syringe needle removal and lithium heparin manual de-capping and re-capping are critical workflow steps that can contaminate the syringe nozzle, the rim of the tube, and the inside of the tube.There is no evidence that the cobas p 512 instrument caused cross-contamination.The investigation did not identify a product problem.

• Brand Name: COBAS P 512 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18384339
• MDR Text Key: 331223338
• Report Number: 1823260-2023-04170
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): Y
• Reporter Country Code: VM
• 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: 01/05/2024

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: P 512
• Device Catalogue Number: 08484708001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/05/2024
• 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