FDA Adverse Event Malfunction Summary report: N

ARCHITECT I2000 ANALYZER

MDR report key: 2070006 · Received April 26, 2011

Report

Report Number: 3005094123-2011-00004
Event Type: Malfunction
Date Received: April 26, 2011
Date of Event: March 22, 2011
Report Date: April 4, 2011
Manufacturer: ABBOTT MANUFACTURING, INC.
Product Code: DHA
PMA / PMN Number: K983212
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION: WASH ZONE MANIFOLDS, WASH ZONE 2 PROBES. A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE ACCOUNT. THE FSR REPLACED THE WASH ZONE MANIFOLDS, REPLACED THE PROBES IN WASH ZONE 2 AND CLEANED THE PROCESS PATH AFTER WHICH NO FURTHER ISSUES WERE REPORTED. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

Additional Manufacturer Narrative · 1

(B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative · 1

(B)(4). THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME ABBOTT ARCHITECT TOTAL B-HCG REAGENT, (B)(4) MANUFACTURING SITE. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME ABBOTT ARCHITECT I2000 ANALYZER, (B)(4) MANUFACTURING SITE.

Description of Event or Problem · 1

THE ACCOUNT STATED THAT AN INITIAL ARCHITECT TOTAL B-HCG RESULT OF 69.82 MIU/ML WAS GENERATED. THE SAMPLE WAS REPEATED AND A RESULT OF < 1.2 MIU/ML WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ARCHITECT I2000 ANALYZER	AUTOMATED IMMUNOASSAY ANALYZER	DHA	ABBOTT MANUFACTURING, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1				ARCHITECT TOTAL B-HCG 7K78-25 LOT UNKOWN\| ARCHITECT TOTAL B-HCG 7K78-25 LOT UNKOWN\| ARCHITECT I2000 LN 3M74-01 SN (B)(4)