DIMENSION? DF119 SMN 10711991

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-01-12 for DIMENSION? DF119 SMN 10711991 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.

Event Text Entries

[64597046] The customer contacted the siemens customer care center (ccc). The cause of the discordant amm results is unknown. The customer also stated that they had been having other instances of abnormal assay flags and low qc results. 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.
Patient Sequence No: 1, Text Type: N, H10


[64597047] 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. A redraw sample was tested on the same instrument and a higher result was obtained and reported. The higher result was in accord with physician expectations. There is no indication that patient treatment was altered or prescribed on the basis of the discordant low amm result. There are no reports of patient intervention or adverse health consequences as a result of the discordant low amm result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00043
MDR Report Key6245152
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-01-12
Date of Report2017-01-12
Date of Event2016-12-09
Date Mfgr Received2016-12-13
Device Manufacturer Date2016-08-11
Date Added to Maude2017-01-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAMES MORGERA
Manufacturer StreetGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer StreetGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal Code197146101
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2517506-12/27/2016-004-R
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION?
Generic NameDIMENSION? AMM AMMONIA FLEX? REAGENT CARTRIDGE
Product CodeJIF
Date Received2017-01-12
Catalog NumberDF119 SMN 10711991
Lot NumberEA7223
Device Expiration Date2017-08-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer AddressGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101


Patients

Patient NumberTreatmentOutcomeDate
10 2017-01-12

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