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

Model Number MPA

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer questioned abnormal results a sample for one patient that was aliquoted by the modular pre-analytic (mpa) system.The clinical chemistry analyzer used for the testing was not provided.Based on the data provided, the sample was erroneous for sodium (na), potassium (k), urea and creatinine.The initial na result was 152 (unit of measure not provided), the initial k result was 9.2 (unit of measure not provided), the initial urea result was 27.2 mmol/l and the initial creatinine result was 1206 (unit of measure not provided).These results were reported outside of the laboratory.The patient was sent to the "aed" where a new sample was obtained from the patient and tests were "normal." the actual results were not provided.The original primary sample tube was repeated and the results were normal.The repeat na result was 146, the repeat k result was 4.5, the repeat urea result was 4.9 mmol/l and the repeat creatinine result was 70.The customer believes the mpa aliquot cup was possibly contaminated with urine which affected the initial results received.The customer¿s unused clean cups sit directly below the sample loading area in open trays.The customer has now moved the trays containing the unused clean cups away from the sample loading area and they are now covered.There was no allegation that an adverse event occurred.The patient was discharged from the "aed" no reagent lot numbers or expiration dates were provided.

Manufacturer Narrative

A specific root cause was not identified.Additional information was requested for investigation but was not provided.In an effort to confirm whether the sample was contaminated, the patient sample was spiked with urine to see the effect on the results.The experiment showed a similar erroneous result.Based on the information available, there is no indication this issue was caused by the mpa system.The mpa was checked and found to be operating within specification.The customer¿s unused clean cups sit directly below the sample loading area in open trays.The customer has now moved the trays containing the unused clean cups away from the sample loading area and they are now covered.Mishandling of the sample prior to going on the mpa may have been the cause of the issue.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• 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: 7045264
• MDR Text Key: 93450641
• Report Number: 1823260-2017-02681
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/12/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/20/2017
• Supplement Dates Manufacturer Received: 11/01/2017
• Supplement Dates FDA Received: 01/12/2018
• 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