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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRINITY BIOTECH USA CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG EIA

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TRINITY BIOTECH USA CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG EIA Back to Search Results
Catalog Number 25029
Device Problem Off-Label Use (1494)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2018
Event Type  Injury  
Event Description
Bio-rad technical support was contacted on (b)(6) 2018 by a bio-rad account manager on behalf of the customer at cerritos reference lab. The customer had a question as to how they should be reporting results for captia¿ (b)(6). The customer had switched from rpr testing to captia¿ (b)(6) igg testing during the third week of (b)(6) 2018, and the customer was reporting the captia¿ syphilis (t. Pallidum) igg results out as rpr results. Bio-rad technical support informed the customer that they have been reporting out the results incorrectly, and provided the information as to how the results should be reported. As part of the incident investigation bio-rad technical support discovered that the customer was running captia¿ (b)(6) igg for tests that were ordered as rpr, and that the tests were reported as rpr. The customer reported that they have sent a letter out informing all of their clinics of the situation, and that the customer will take corrective action to resolve the incident. This incident is user error as the customer did not perform the test that was ordered by the physician, and the customer reported out results incorrectly. Because results were reported out incorrectly there is potential for harm to the patient due to delayed treatment or misdiagnosis.
 
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Brand NameCAPTIA¿ SYPHILIS (T. PALLIDUM) IGG
Type of DeviceEIA
Manufacturer (Section D)
TRINITY BIOTECH USA
2823 girts road
jamestown NY 14701
Manufacturer (Section G)
TRINITY BIOTECH USA
2823 girts road
jamestown NY 14701
Manufacturer Contact
david bhend
6565 185th ave ne
redmond, WA 98052
4254981758
MDR Report Key7626067
MDR Text Key111980420
Report Number3022521-2018-00003
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number25029
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/21/2018 Patient Sequence Number: 1
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