MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PREA PREALBUMIN; PREALBUMIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 20764655322

Device Problem High Test Results (2457)

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

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for prea prealbumin (prea) on a cobas 8000 c 502 module (c502).It was asked, but it is not known if an erroneous result was reported outside of the laboratory.The sample resulted as 32 mg/dl when tested on the c502 analyzer.When the sample was tested on an olympus au480 analyzer using the n-assay tia prealbumin nittobo (made in (b)(6)), it resulted as 3.5 mg/dl.It is unknown which value is correct.No adverse events were alleged to have occurred with the patient.The c502 analyzer serial number was asked for, but not provided.

Manufacturer Narrative

The complained sample was found to be turbid.The sample was evaluated using immunoelectrophoresis and was found to contain polyclonal igg and igm-kappa.The sample was assumed to be turbid due to the presence of these abnormal immunoglobulins.After immunoabsorption of the igg with protein g, the prea measuring results on c502 went down.It is assumed that the root cause for the falsely elevated results is caused by igm-kappa and/or by turbidity due to high igg concentration.Gammopathy, in particular type igm (b)(4), may cause unreliable results as stated in product labeling.

• Brand Name: PREA PREALBUMIN
• Type of Device: PREALBUMIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6913239
• MDR Text Key: 89945690
• Report Number: 1823260-2017-02191
• Device Sequence Number: 1
• Product Code: JZJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20764655322
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• 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
• Patient Age: 87 YR
• Patient Weight: 51