MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA 7 PLUS; AUTOMATED PREANALYTICAL SYSTEM

Catalog Number 03530752001

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that they received a transport error on their mpa pre-analytics system.It was determined that there were 2 racks, containing ten samples, which did not get centrifuged.These racks were sent to 2 cobas 8000 analyzer lines, where they were processed.Of the ten samples, seven had erroneous results reported outside of the laboratory for creatinine plus ver.2 (crea), ion selective electrode (ise) potassium - k, magnesium gen.2 (mg), and glucose (glc).Refer to the attachment for results from all seven affected samples.The initial results were from the racks that were not centrifuged.The samples were then centrifuged and repeated.The repeat results were believed to be correct and corrected reports were issued.The patients were not adversely affected.The crea reagent lot number was 617455 and the mg reagent lot number was 618718.The crea and mg reagent expiration dates were asked for, but not provided.The ise potassium electrode and glc reagent lot numbers and expiration dates were asked for, but not provided.The customer found loose labels on the sample tubes and found part of a label on the belt of the mpa system.The label was removed from the belt.The customer re-set the mpa system and no further issues occurred.The customer declined a service visit.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.No system malfunction was found.

• Brand Name: MPA 7 PLUS
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5330526
• MDR Text Key: 34524512
• Report Number: 1823260-2015-06125
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

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: 03530752001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1