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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS MULTISTIX 10-SG 100 USA; MULTISTIX 10 SG

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SIEMENS HEALTHCARE DIAGNOSTICS MULTISTIX 10-SG 100 USA; MULTISTIX 10 SG Back to Search Results
Catalog Number 10336425
Medical Device Problem Code False Positive Result (1227)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/11/2016
Additional Manufacturer Narrative
The customer states she has prescribed antibiotics to patients with elevated results and has ordered further testing.The customer has received replacement strips and is fully operational on the new strips.
 
Event or Problem Description
The customer reported that some leukocyte results were incorrectly reported out due to deteriorated strips and patients were prescribed antibiotics that were not necessary.Specific data was not provided on these samples.
 
Additional Manufacturer Narrative
The reagent was returned for investigation.The investigation of the desiccants demonstrated that the strips were exposed to excessive moisture.Visual appearance of strips also consistent with moisture exposure.Per the multistix ifu: "protection against exposure to light, heat, and ambient moisture is mandatory to guard against altered reagent reactivity"."discoloration or darkening of the test pads may indicate deterioration." the customer is operational.
 
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Brand Name
MULTISTIX 10-SG 100 USA
Common Device Name
MULTISTIX 10 SG
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
MDR Report Key6082693
Report Number3002637618-2016-00138
Device Sequence Number1363110
Product Code JIR
Combination Product (Y/N)N
PMA/510(K) Number
K992257
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Type of Report Initial,Followup
Report Date (Section B) 12/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Expiration Date06/30/2017
Device Catalogue Number10336425
Device Lot Number512065
Was Device Available for Evaluation? Yes
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 10/11/2016
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date11/07/2016
Supplement Report FDA Received Date12/12/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
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