MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANALYTICAL P MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 03284549001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received an erroneous result for one patient sample tested for calcium.The customer stated that the calcium result was underestimated.The sample initially resulted as 9.45 mg/dl on (b)(6) 2015.The customer had the impression that results were recovering low on (b)(6) 2015, so they repeated the sample to check.The sample was repeated on (b)(6) 2015, resulting as 7.56 mg/dl.Both results were reported outside of the laboratory.The patient was not adversely affected.The calcium 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.Additional information required for the investigation was asked for, but not provided.Based on the provided information, a precision issue is apparent.Quality control fluctuations were observed in the provided data.A reagent issue can be excluded since successful calibrations were seen both before and after the incident occurred.The root cause of issue is assumed to be related to system maintenance.

• Brand Name: ANALYTICAL P MODULE
• Type of Device: CLINICAL CHEMISTRY 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: 5019021
• MDR Text Key: 23864327
• Report Number: 1823260-2015-03996
• Device Sequence Number: 0
• Product Code: JFP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K953239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03284549001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 08/04/2015
• 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