FDA Adverse Event Malfunction Summary report: N

THERMAL ANALYZER

MDR report key: 1821365 · Received August 26, 2010

Report

Report Number: 2245578-2010-00067
Event Type: Malfunction
Date Received: August 26, 2010
Date of Event: October 25, 1995
Report Date: August 25, 2010
Manufacturer: ABBOTT POINT OF CARE INC.
Product Code: JJE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS LATE MDR IS A RETROSPECTIVE FILING. THE RETROSPECTIVE FILING IS IN RESPONSE TO ABBOTT POINT OF CARE INC (B)(4). THE I-STAT PORTABLE CLINICAL ANALYZER AND THE I-STAT 1 ANALYZER OPERATE ON 9 VOLT BATTERIES. ACROSS THESE BATTERIES AND AT OTHER NODES CONNECTING TO THESE BATTERIES, A NUMBER OF TANTALUM CAPACITORS EXIST IN THE CIRCUITRY. SHOULD THE CAPACITORS EXPERIENCE A RELIABILITY FAILURE, A LOW INTERNAL IMPEDANCE PATH MAY FORM IN THE CAPACITOR, RESULTING IN EXCESSIVE POWER DISSIPATION IN THE COMPONENT AS THE BATTERY IS EFFECTIVELY SHORT CIRCUITED. THERE ARE 4 OF THESE CAPACITORS IN EACH ANALYZER MODEL THAT CONNECT DIRECTLY TO THE BATTERIES. FOR THE I-STAT 1, THE REFERENCE DESIGNATORS FOR THE COMPONENTS ARE C4, C13, C26 AND C21. FOR THE I-STAT PORTABLE CLINICAL ANALYZER, THE REFERENCE DESIGNATORS ARE C169, C176, C180 AND C186. IN ADDITION, IT HAS BEEN DETERMINED DEFECTIVE BATTERY CARRIERS AND FLEX CABLES MAY ALSO CAUSE THE BATTERIES TO BE SHORT CIRCUITED. (B)(4).

Description of Event or Problem · 1

THIS LATE MDR IS A RETROSPECTIVE FILING. ON (B)(6) 1995, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT 1 ANALYZER WAS HOT TO TOUCH. BASED ON THE INFO AT THE TIME, THERE WAS NO INJURY ASSOCIATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	THERMAL ANALYZER	THERMAL ANALYZER	JJE	ABBOTT POINT OF CARE INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1