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

Model Number P MODULE

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer questioned multiple results for dialysis patients tested for urea/bun kinetic uv assay for urea/urea nitrogen (urea/bun) on a modular p instrument.Data was provided for 108 patient samples.Of this data, 14 patient samples were erroneous.The erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The lot number of the reagent was 27324901 with an expiration date of 31-aug-2018.The customer¿s quality control results were scattered quite a bit and coefficient of variation (cv) results were not good.The field service engineer (fse) visited the customer site and found that the mixer and halogen bulb were defective.The fse replaced reagent and sample probes.Gear pump pressure was checked.All cv results from hardware performance checks were back within range.No more erroneous results were produced.The investigation determined that the mechanical failure of the mixer and halogen bulb found by the fse was most likely the root cause of the event.

• Brand Name: ANALYTICAL P MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• 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: 7032511
• MDR Text Key: 93221756
• Report Number: 1823260-2017-02610
• Device Sequence Number: 0
• Product Code: CDQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P MODULE
• Device Catalogue Number: 03284549001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1