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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TSH

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A.I.D.D LONGFORD ALINITY I TSH Back to Search Results
Catalog Number 07P48-30
Device Problems Unable to Obtain Readings (1516); Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
A product recall letter was issued to customers who received shipments of the affected alinity reagents to inform them of the manufacturing issue identified with the reagent cartridge bottle necks. The letter instructs the customer to manually inspect each reagent cartridge in inventory before use. Stat assays, alinity i stat high sensitive troponin- i and alinity i total b-hcg, should be inspected first as a priority to ensure no delay in testing for those assays. Removals and corrections report number: 3005094123-11/21/18-002-r.
 
Event Description
The customer observed error codes 5794 (reagent carousel load error) and 5672 (reagent supply center load error) while loading alinity i tsh reagent lot 92291ui00 on the alinity i processing module. There was no report of any patient impact due to the potential delay in generating tsh results.
 
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Brand NameALINITY I TSH
Type of DeviceTSH
Manufacturer (Section D)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford NA
EI NA
Manufacturer (Section G)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford NA
EI NA
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key8157141
MDR Text Key130473591
Report Number3005094123-2018-00231
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 12/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/24/2019
Device Catalogue Number07P48-30
Device Lot Number92291UI00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number3005094123-11/21/18-002R

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