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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MYERS-STEVENS GROUP TARGET HCG URINE CONTROL SET
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MYERS-STEVENS GROUP TARGET HCG URINE CONTROL SET Back to Search Results
Catalog Number 30-0103
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2014
Event Type  malfunction  
Event Description
On (b)(6) /2014 a point of care testing user at (b)(6) medical center,(b)(6) reported urine hcg quality control results were testing opposite of their intended reactions.The qc bottles were retested in the clinical laboratory and results confirmed.Reported deviation to the manufacturer on (b)(6) 2014.We were instructed to return the kit and replacement material would be shipped to our facility.According to the manufacturer there had been no other incidents of this nature reported.On (b)(6) 2014 one of our other facilities, (b)(6) hospital experienced the same deviation in the clinical laboratory.The testing was repeated and results were confirmed.The manufacturer was contacted again.The contact person still claimed that no other incidents of this kind had been reported.Replacement kits received.Additional lot numbers available on site at each facility for qc testing, these lots were obtaining the expected results.As no time was pt care in jeopardy or qc not performed.Event reappeared after reintroduction: #1 and #2: yes.
 
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Brand Name
TARGET HCG URINE CONTROL SET
Type of Device
TARGET HCG URINE CONTROL SET
Manufacturer (Section D)
MYERS-STEVENS GROUP
montebello CA
MDR Report Key3999725
MDR Text Key4694542
Report NumberMW5037694
Device Sequence Number1
Product Code JHJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/04/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2016
Device Catalogue Number30-0103
Device Lot Number0103401-C1RP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2014
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
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