FDA Adverse Event Injury Summary report: N

OMNIPOD INSULIN MANAGEMENT SYSTEM

MDR report key: 12129250 · Received July 7, 2021

Report

Report Number: 3004464228-2021-11003
Event Type: Injury
Date Received: July 7, 2021
Date of Event: June 21, 2021
Report Date: June 21, 2021
Manufacturer: INSULET CORPORATION
Product Code: LZG
UDI-DI: 20385081120033
PMA / PMN Number: K192659
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO (B)(4) COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6 PER ISO ISO11135 AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO (B)(4) AND STERILITY PER ISO10993 PRIOR TO RELEASE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION AT THE PODS INSERTION SITE WHILE WEARING THE DEVICE FOR MORE THAN 48 HOURS ON THE ARM. THE SITE HAD PUSS COMING OUT OF IT. THE PATIENT WENT IN TO SEE THEIR PRIMARY CARE PHYSICIAN AND DIAGNOSED WITH AN INFECTION. THE PATIENT WAS TREATED WITH BACTRIM 800/150 TAB AND WAS DIRECTED TO TAKE 1 TABLET EVERY 12 HOURS FOR 5 DAYS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1023229	OMNIPOD INSULIN MANAGEMENT SYSTEM	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	19191	L71165	20385081120033

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention