CLINICAL CHEMISTRY PHOSPHORUS 7D71-21

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-06-03 for CLINICAL CHEMISTRY PHOSPHORUS 7D71-21 manufactured by Abbott Manufacturing, Inc..

Event Text Entries

[1505422] The customer stated error code 3103 (unable to process test, liquid contact broken during aspiration for reagent 2 pipettor) was occurring on the architect c8000 analyzers. The error was only occurring with the phosphorus assay. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5


[8651803] (b)(4). Evaluation: insufficient aspiration of the r2 reagent. The clinical chemistry phosphorus reagent, list number 7d71-21 has demonstrated imprecision, primarily in the form of results with less than flags and in error code 3106/3103 (unable to process test, liquid contact broken during aspiration of reagent 2 pipettor). Additionally, there is a potential for falsely depressed patient values to be generated. The investigation has revealed the cause of this issue is related to the insufficient aspiration of the r2 reagent. In response to this issue a product recall was initiated. All current customers who have received clinical chemistry phosphorus, list number 7d71-21 of any lot, and have an architect c8000, architect c16000 or aeroset analyzer were instructed to discontinue use and destroy any remaining inventory. Replacement kits (7d71-31 or 7d71-22) were made available to replace 7d71-21. Product labeling was reviewed and found to adequately address the causes and corrections to error code 3103 and 3106, unable to process test, liquid contact broken during aspiration for reagent 2 pipettor. Additionally, when values less than the linearity or limit of detection are produced, the system generates a less than flag ( < ) to indicate to the operator that the result is outside the dynamic or linear range for the assay and should be reviewed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2018433-2010-00100
MDR Report Key1709223
Report Source01,05
Date Received2010-06-03
Date of Report2010-02-22
Date Mfgr Received2010-05-12
Date Added to Maude2010-12-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactNOEMI KONDOS RN, BSN
Manufacturer Street200 ABBOTT PARK ROAD DEPT. 09B9, AP50
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone8479375120
Manufacturer G1ABBOTT MANUFACTURING, INC.
Manufacturer Street820 MISSION ST.
Manufacturer CitySOUTH PASADENA CA 91030
Manufacturer CountryUS
Manufacturer Postal Code91030
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2018433-5/4/10-002-R
Event Type3
Type of Report3

Device Details

Brand NameCLINICAL CHEMISTRY PHOSPHORUS
Generic NameFOR THE QUANTITATION OF PHOSPHORUS IN HUMAN SERUM, PLASMA, OR URINE
Product CodeCEO
Date Received2010-06-03
Catalog Number7D71-21
Lot Number81040HW00
Device Expiration Date2010-07-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MANUFACTURING, INC.
Manufacturer Address820 MISSION ST. SOUTH PASADENA CA 91030 US 91030


Patients

Patient NumberTreatmentOutcomeDate
10 2010-06-03

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