FDA Adverse Event Injury Summary report: N

ACCU-CHEK SPIRIT

MDR report key: 1020690 · Received March 28, 2008

Report

Report Number
2183996-2008-00419
Event Type
Injury
Date Received
March 28, 2008
Date of Event
March 7, 2008
Report Date
March 7, 2008
Manufacturer
DISETRONIC MEDICAL SYSTEMS
Product Code
LZG
PMA / PMN Number
K060876
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

THE PT'S WIFE REPORTED THE PT EXPERIENCED SOME LOW BLOOD GLUCOSE READINGS OF 53 MG/DL IN 2008 AND 52 MG/DL ON THE NEXT DAY. SHE STATED THAT FOR THE FIRST READING, SHE CORRECTED HIS READING BY GIVING HIM APPLE JUICE AND FOR THE SECOND READING SHE HAD HIM DISCONNECT FROM HIS INSULIN INFUSION DEVICE AND THEN GAVE HIM 3 GLUCOSE TABLETS. SHE SAID SHE TESTED HIM AGAIN 15 MINUTES LATER AND HIS READING WAS ONLY UP TO 55 MG/DL, SO SHE GAVE HIM SOME SUGAR. SHE STATED HIS BLOOD GLUCOSE WAS 139 MG/DL ABOUT 1.5 HRS LATER AND THE PT IS CURRENTLY "FEELING FINE" WITH A READING OF 231 MG/DL. DURING TROUBLESHOOTING, THE PT'S WIFE STATED THE PT IS INSULIN RESISTANT. THE TIME, HISTORY, AND BASAL RATES WERE CHECKED ON HIS INFUSION DEVICE AND FOUND TO BE ACCURATE. TROUBLESHOOTING DID NOT FIND ANY PROD ISSUES. THE PT'S WIFE WAS ADVISED TO CONTACT THE PT'S DOCTOR TO LET HIM KNOW ABOUT THE LOW READINGS. ON FOLLOW UP ELEVEN DAYS LATER, THE PT'S WIFE STATED THE PT WAS CURRENTLY IN THE HOSP WITH A DIAGNOSIS OF ACUTE RENAL FAILURE. SHE STATED SIX DAYS AFTER THE ORIGINAL DATE, SHE NOTICED HE WAS RETAINING FLUID AND HIS FEET AND LEGS WERE SWOLLEN. SHE SAID SHE CALLED THE PT'S DOCTOR THE NEXT MORNING AND HE IMMEDIATELY HOSPITALIZED THE PT. THE PROD WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R INSULIN| INSULIN INFUSION SET