MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANALYTICAL E MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number 03739040692

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The field application specialist first reported that he had been at this site on (b)(6)2015 to install the rbc folate application on the customer's analyzer.He said that he did not dilute controls for this test in the same manner as patient samples as directed.He stated that running the controls without dilution caused build up in the measuring cell of the analyzer.When the customer ran controls on (b)(6)2010, these were found to be out of range.The analyzer was not in use on (b)(6)2015 and (b)(6)2015.The field service representative checked the analyzer on (b)(6)2015 due to "abnormal measuring cell condition" errors that the customer had been getting.He determined that the analyzer high voltage was out of specification.He adjusted the high voltage so that it was within specifications.The customer ran calibrations and quality controls.After the service actions, the customer repeated approximately (b)(6) patient samples that were tested on (b)(6)2015.The customer mentioned that they issued corrected reports for a total of (b)(6) patient samples.Of the affected samples, the customer provided an example of one patient sample that had an erroneous vitamin b12 (b12) result.The sample initially resulted as approximately 705 pmol/l and this value was reported outside of the laboratory.The sample was repeated on (b)(6)2015, resulting as approximately 425 pmol/l.The repeat result was believed to be correct and a corrected report was issued.The patient was not adversely affected.The b12 reagent lot number and expiration date were asked for, but not provided.A specific root cause could not be determined based on the provided information.The most likely root cause would be related to mishandling of the quality control material.The quality control material could cause a contamination of the measuring cell, which could lead to a signal shift.The customer has not reported any further issues.

• Brand Name: ANALYTICAL E MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• 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: 5229244
• MDR Text Key: 31338008
• Report Number: 1823260-2015-04565
• Device Sequence Number: 0
• Product Code: CGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03739040692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 11/02/2015
• 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