MAUDE Adverse Event Report: SIEMENS SIEMENS AMM AMMONIA RGT REF #DF119

Lot Number BC6258

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/09/2016

Event Type  Malfunction  

Event Description

We get an "abnl assay" next to qc or patient results. When the report prints out, you get a flag "abnl assay". This flag means you cannot report the test for qc or patients. In order to fix this problem, we take the reagent flex off the analyzer and put it back on, and we rerun the qc or patient (because it flats randomly on the qc or patient result).

• Brand Name: SIEMENS AMM
• Type of Device: AMMONIA RGT REF #DF119
• Manufacturer (Section D): SIEMENS ; newark DE 19714
• MDR Report Key: 5434029
• MDR Text Key: 38386630
• Report Number: MW5060148
• Device Sequence Number: 1
• Product Code: JIF

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 02/09/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/09/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device EXPIRATION Date: 09/14/2016
• Device LOT Number: BC6258
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage