MAUDE Adverse Event Report: MIO; INSET II 60/6 PCC BLUE

Model Number	MMT-943
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that on (b)(6) 2020, a child patient faced a device related adverse event with a diagnosis of urinary tract infection.Therefore, the patient went into urgent care and was prescribed antibiotic for ten days.The patient had elevated ketone and blood glucose levels due to illness.Moreover, he was prescribed with cefdinir 300 mg twice daily for 7 days on the day of incident ((b)(6) 2020).On (b)(6) 2020, the doctor counseled stating that symptoms were improving but patient continued complaining of back pain.Further, the doctor counseled patient to discontinue cefdinir and wrote a new prescription for augmentin 500-125 mg twice daily for ten days.According to medical records, patient had symptoms which included chills, fever, abdominal pain, mild nausea, urinary bowel changes (mild dysuria & frequent urination), & back pain.On (b)(6) 2020, all the symptoms were resolved and recovered without sequela.In another event, on (b)(6) 2020, the child patient's site was changed and then he had a low carbohydrate dinner.While he was running around, they did not notice his blood glucose level was rising.At 01:00 am, when they checked, his blood glucose level was above 300 mg/dl and ketone level was 2.4 mmol/l.He also experienced minor stomachache and was feeling generally icky.Therefore, they changed the set again, took three units of manual injection and 0.9 unit of through new set.Patient's blood glucose level was 386 mg/dl at the time of incident.On (b)(6) 2020, in the morning, his ketone and blood glucose level started resolving slowly and when they removed the cannula, it was noticed that it was kinked at 90 degree.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC BLUE
• MDR Report Key: 10668811
• Report Number: 3003442380-2020-00423
• Device Sequence Number: 14139079
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 09/01/2022
• Device Model Number: MMT-943
• Device Lot Number: 5296181
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1