FDA Adverse Event Malfunction Summary report: N

GEM PREMIER 4000

MDR report key: 831729 · Received February 8, 2007

Report

Report Number: 1217183-2007-00001
Event Type: Malfunction
Date Received: February 8, 2007
Report Date: February 8, 2007
Manufacturer: INSTRUMENTATION LABORATORY CO.
Product Code: CHL
PMA / PMN Number: k061974
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

IL IS CURRENTLY INVESTIGATING THIS INCIDENT AND EVALUATING THE ASSOCIATED RISK. BASED ON THE OUTCOME, IL WILL EXPEDITE ANY INDICATED CORRECTIVE ACTION TO THE FIELD AND NOTIFY REGULATORY AGENCIES AS APPROPRIATE.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT THE CARTRIDGE IN USE ON THEIR GEM PREMIER 4000 EXPERIENCED REPEATED SODIUM DRIFT ERRORS, BUT THE ANALYTE CHANNEL WAS NOT PERMANENTLY DISABLED BY THE INSTRUMENT. THE AFFECTED CARTRIDGE WAS CHANGED AND RESULTS VERIFIED AS CORRECT. NOTES: CUSTOMER REPORTED THE INCIDENT TO THEIR LOCAL REGULATORY AUTHORITY, THE MHRA (MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY) IN ANOTHER COUNTRY, AS A "MINOR" EVENT. THERE IS NO INDICATION FROM THE CUSTOMER OF AN ADVERSE EVENT OR ANY CHANGES TO PT TREATMENT BASED ON THE INCORRECT SODIUM RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GEM PREMIER 4000	BLOOD GAS, ELECTROLYTE, CO-OX SYSTEM	CHL	INSTRUMENTATION LABORATORY CO.	4000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	*