ACCU-CHEK SPIRIT

MDR report key: 1810137 · Received August 17, 2010

Report

Report Number: 2183996-2010-01630
Event Type: Injury
Date Received: August 17, 2010
Date of Event: July 22, 2010
Report Date: July 24, 2010
Manufacturer: ROCHE INSULIN DELIVERY SYSTEMS INC.
Product Code: LZG
PMA / PMN Number: K060876
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

NO PRODUCT WILL BE RETURNED FOR EVALUATION.

Description of Event or Problem · 1

ON (B)(6) 2010, NURSE CALLED TO REQUEST ASSISTANCE CHECKING PATIENT'S BASAL RATES ON HIS INFUSION DEVICE. VERIFIED THE PATIENT WAS STILL CONNECTED TO THE DEVICE. NURSE REPORTED THE INFUSION DEVICE WAS IN RUN MODE AND OPERATING WITHIN THE BASAL RATES. NURSE DID NOT WANT TO MAKE ANY CHANGES TO PATIENT'S BASAL RATES AT THE TIME OF THE CALL. NURSE REPORTED PATIENT WAS BROUGHT TO THE HOSPITAL EMERGENCY ROOM BECAUSE OF DEHYDRATION AND HYPERGLYCEMIA. NURSE REPORTED PATIENT'S BLOOD GLUCOSE WAS OVER 500 MG/DL. NURSE DID NOT KNOWN THE DETAILS OF THE INCIDENT LEADING UP TO THE PATIENT'S HOSPITALIZATION, SO SHE BROUGHT PATIENT'S WIFE ON THE LINE. PATIENT'S WIFE REPORTED PATIENT WAS TAKEN TO THE HOSPITAL EMERGENCY ROOM BECAUSE HE WAS VERY WEAK AND HAD SEVERE DIARRHEA. WIFE STATED PATIENT HAD NOT EATEN SINCE (B)(6) 2010 AND WAS ALSO SUFFERING FROM AN INFECTION. PATIENT'S WIFE REPORTED PATIENT HAS AN APPOINTMENT TO SEE HIS ENDOCRINOLOGIST. SEVERAL ATTEMPTS WERE MADE TO FOLLOW-UP WITH THE PATIENT; WAS UNSUCCESSFUL. NO PRODUCT RETURN WAS REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK SPIRIT	INSULIN INFUSION PUMP	LZG	ROCHE INSULIN DELIVERY SYSTEMS INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Hospitalization\| O\| R	INSULIN (DATE OF TREAMENT (B)(6))\| INSULIN INFUSION SET (DATE OF TX (B)(6))