MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA-P MOD STD B + 2ND ACU; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Catalog Number 03369935001

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) found two online aliquoter (aqn) heads were leaking.The fse replaced the aqn heads and the issue was resolved.The investigation is ongoing.

Event Description

The initial reporter complained of an issue with their modular pre analytics module (mpa).The customer complained that serum was overflowing from one of the drip trays and there were drops of serum "all over" the equipment.The customer confirmed the drip tray and filter were correctly in place.There was no allegation of questionable or discrepant results due to this issue, however, there is a possibility of cross contamination of patient samples due to the issue.

Manufacturer Narrative

The aliquoter heads were requested for investigation but were not available.Since the product was not available, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: MPA-P MOD STD B + 2ND ACU
• Type of Device: CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 13175179
• MDR Text Key: 284645275
• Report Number: 1823260-2022-00038
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/08/2022

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 Catalogue Number: 03369935001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/08/2022
• 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