TRIAGE TOTAL 5 CONTROL L1 88753

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2017-01-04 for TRIAGE TOTAL 5 CONTROL L1 88753 manufactured by .

Event Text Entries

[63884748] Mdr is being filed due to field action ref-2027969-10/12/16-004-c. Customer's complaint was replicated with in-house testing of the code chip of retain lot c3233a. Code chip ranges did not match ev card ranges. The manufacturing records for the control lot were reviewed and the lot met release specifications. A capa, (b)(4), was initiated to address this issue. Date of this report selected as 9/29/2016 to reflect the date in which field corrective action 2027969-10/12/16-004-c was initiated.
Patient Sequence No: 1, Text Type: N, H10


[63884749] The customer attempted to run the total 5 control level 1 at 2 stdev with a d-dimer result outside of the expected range low at 386 ng/ml (2 stdev: 390-584 ng/ml). The customer repeated the test with the total 5 control level 1 at 1 stdev. The d-dimer result was outside of the expected range low at 401 ng/ml (1 stdev: 438-536 ng/ml). The customer also reported a low bias and results outside of expected ranges for multiple total 5 controls and calibrators. A later retest using an alternate lot of total 5 controls produced results within the expected range.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027969-2017-00007
MDR Report Key6223482
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2017-01-04
Date of Report2016-09-29
Date Mfgr Received2016-12-14
Date Added to Maude2017-01-04
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 ContactYA-LING KING
Manufacturer Street9975 SUMMERS RIDGE ROAD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8588052084
Single Use3
Remedial ActionRL
Previous Use Code3
Removal Correction Number2027969-10/12/16-004-C
Event Type3
Type of Report3

Device Details

Brand NameTRIAGE TOTAL 5 CONTROL L1
Generic NameMULTI-ANALYTE CONTROLS
Product CodeJJY
Date Received2017-01-04
Model Number88753
Lot NumberC3233A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2017-01-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.