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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBUMIN GEN.2 BROMCRESOL GREEN DYE-BINDING, ALBUMIN

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ROCHE DIAGNOSTICS ALBUMIN GEN.2 BROMCRESOL GREEN DYE-BINDING, ALBUMIN Back to Search Results
Catalog Number 05166861190
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2016
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

The customer complained of issues with a new lot of albumin gen. 2 (alb2) reagent that doesn't seem to be maintaining calibration. The new alb2 reagent lot number is 119319 expiring 02/28/2017 received on 01/11/2016. The old lot number was 619340 and the customer is not having any issues with that lot. The new reagent lot was loaded onto the instrument on (b)(6) 2016 and the customer received calibration errors. Quality controls (qc) were in range. As the reagent pack was used up, the qc values dropped out of range. The customer repeated 35 patient samples tested for alb2. Data was provided for 30 patient samples. Of the data provided, 7 patient samples were erroneous and reported outside of the laboratory. Corrected reports were issued after repeat testing was performed. (b)(6). No adverse event occurred. The c 702 analyzer serial number (b)(4). A specific root cause could not be identified. It was noted that the reagent packs may have frozen during delivery on (b)(6) 2016 as the same reagent pack lot delivered on (b)(6) 2016 was not affected and is holding their calibration. The instrument was checked and calibration and quality controls were acceptable.

 
Manufacturer Narrative

The customer no longer has the specific reagent packs to return for investigation. The root cause of the issue is assumed to be the deterioration of the individual reagent packs that the customer complained about. Factors such as storage or shipment conditions can influence the quality of the product received. The customer is still using the same alb2 lot number. The customer has not had any additional calibration or quality control issues with the lot number in use. Alb2 tests are being run with no problems. No other complaints have been reported for this lot.

 
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Brand NameALBUMIN GEN.2
Type of DeviceBROMCRESOL GREEN DYE-BINDING, ALBUMIN
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 Key5415990
MDR Text Key38314737
Report Number1823260-2016-00118
Device Sequence Number1
Product Code CIX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/08/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2017
Device Catalogue Number05166861190
Device LOT Number11931901
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
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

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