FDA Adverse Event Malfunction Summary report: N

ARCHITECT IPTH

MDR report key: 2970447 · Received February 20, 2013

Report

Report Number: 3002809144-2013-00019
Event Type: Malfunction
Date Received: February 20, 2013
Report Date: August 17, 2012
Manufacturer: ABBOTT GERMANY
Product Code: CEW
PMA / PMN Number: K063232
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, ACCURACY AND RELEASE TESTING, A LITERATURE REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. ACCURACY TESTING WAS COMPLETED USING LOT 03312E000 AND MET ACCEPTANCE CRITERIA. RELEASE TESTING WAS REVIEWED AND SHOWED THE ASSAY HAS NOT SHIFTED OVER THIS TIME PERIOD. A STUDY TITLED "PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS" WAS REVIEWED WHICH INDICATED THE ARCHITECT IPTH ASSAY CORRELATED WELL AGAINST THE ROCH MODULE E170. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

Description of Event or Problem · 1

THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED A FALSELY ELEVATED IPTH RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED AN IPTH RESULT OF 60, WHILE A BECKMAN ACCESS ANALYZER GENERATED A RESULT OF 36.8. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
74707	ARCHITECT IPTH		CEW	ABBOTT GERMANY		03312E000

Patients

Seq	Age	Sex	Outcome	Treatment
1				LN 01L86-40 SN (B)(4)\| ARCHITECT I1000SR ANALYZER