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

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.

• Brand Name: ALBUMIN GEN.2
• Type of Device: BROMCRESOL 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 Key: 5415990
• MDR Text Key: 38314737
• Report Number: 1823260-2016-00118
• Device Sequence Number: 1
• Product Code: CIX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 05166861190
• Device Lot Number: 11931901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• 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: N
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 64