MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION®; DIMENSION® AMM AMMONIA FLEX® REAGENT CARTRIDGE

Catalog Number DF119 SMN 10711991

Device Problem Low Test Results (2458)

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

Event Date 12/27/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The cause of the discordant amm result is unknown.Siemens healthcare diagnostics is conducting a recall for the dimension® ammonia flex® reagent cartridge/amm df119 (smn # 10711991) kit lots (fb7152, eb7180, ba7194, ea7223, ba7250) and dimension vista® ammonia flex® reagent cartridge / amm k3119 (smn #10711992) kit lots (16187be, 16225bb,16265ab).Siemens healthcare diagnostics has determined that dimension amm (df119) flex reagent cartridge lots fb7152, eb7180, ba7194, ea7223, ba7250 and dimension vista amm (k3119) flex reagent cartridge flex lots 16187be, 16225bb, 16265ab do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay.These lots may exhibit accuracy shifts for patient and/or quality control results; which may cause laboratories to recalibrate more frequently than the 60-day claim in the instructions for use (ifu).An urgent field safety notices (ufsn's) dc17-01.A.Ous.Dm and dc 17.01a.Ous.Dmv were sent to ous customers and an urgent medical device recalls (umdr's) dc17-01.A.Us.Dm and dc 17.01a.Us.Dmv were sent to us customers in december 2016.The ufsn and umdr informs the customers to discontinue use of and discard the affected kit lot.Siemens recommends using an alternate lot of dimension or dimension vista amm siemens is currently investigating the root cause of this issue.

Event Description

A discordant low ammonia (amm) result was obtained on a patient sample on the dimension exl system.The patient result was reported to the physician who questioned the result.The same sample was repeated at another hospital and a higher result was obtained.There are no reports of patient intervention or adverse health consequences as a result of the discordant low amm result.

• Brand Name: DIMENSION®
• Type of Device: DIMENSION® AMM AMMONIA FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6277783
• MDR Text Key: 65771417
• Report Number: 2517506-2017-00057
• Device Sequence Number: 1
• Product Code: JIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2017
• Device Catalogue Number: DF119 SMN 10711991
• Device Lot Number: EA7223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2517506-12/27/2016-004-R
• Patient Sequence Number: 1