MAUDE Adverse Event Report: RANDOX LABORATORIES, LTD. AMMONIA

Catalog Number AM1015

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

Patient samples will recover with a positive bias of approximately 60 umol/l when using ammonia catalogue number am1015 batch 326173.All affected customers have been contacted and instructed to discontinue use and discard, their inventory will be replaced.The ammonia test is generally ordered along with glucose, urea, electrolytes, kidney and liver function tests alp, ast and alt therefore it is not considered a single conclusive diagnostic test to initiate therapy.

• Brand Name: AMMONIA
• Type of Device: AMMONIA
• Manufacturer (Section D): RANDOX LABORATORIES, LTD.; 55 diamond rd.; crumlin, county antrim ; UK
• Manufacturer Contact: 55 diamond rd.; crumlin, county antrim ; 894422413
• MDR Report Key: 4692041
• MDR Text Key: 21081576
• Report Number: 8020890-2015-00001
• Device Sequence Number: 1
• Product Code: JIF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K030873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: AM1015
• Device Lot Number: 326173
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1