MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA; AUTOMATED PREANALYTICAL SYSTEM

Model Number MPA

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.Na.

Event Description

The initial reporter received questionable sodium, potassium, and chloride results for 1 patient sample and questionable sodium and chloride results for 1 patient sample on a cobas 8000 cobas ise module.Refer to the highlighted section of the attachment "pt48857.Pdf" for patient results.The electrode lot numbers and expiration dates were requested, but not provided.The initial results were reported outside of the laboratory.The clinician questioned the results as they did not match the patient's clinical picture.

Manufacturer Narrative

Sections d1-d4 and g5 were updated.The investigation investigated the modular pre-analytic (mpa) system for a root cause since the secondary samples were found to have higher results compared to the primary samples.Error data and log files were reviewed from the mpa and no failure was detected from the information.The aliquot rack was checked via photos and visually onsite.A failure such as a defective barcode or a blocked hole could not be seen.A field service engineer recently performed a leakage check on the aliquoter module which passed.The service engineer also performed an alignment on the module.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10935221
• MDR Text Key: 219198726
• Report Number: 1823260-2020-03065
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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: MPA
• Device Catalogue Number: 05575532001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1