MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A DE C.V DIABETES INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Obstruction of Flow (2423)

Patient Problems Hyperglycemia (1905); Polydipsia (2604)

Event Type  Injury  

Event Description

In accordance with 21 cfr 803.22 (b)(2), we are notifying you that on (b)(6) 2013 patient's wife reported he was faced with elevated blood glucose levels causing him to be admitted into the hospital.Wife stated at lunch the patient had a normal reading of 118 mg/dl.Patient's normal range is 100-140 mg/dl.Wife reported that the patient took his blood glucose level and got a reading over 400 mg/dl at 6:30 pm; patient had not eaten yet.Wife stated the patient attempted to do a bolus of 24.6 units of insulin but he does not think it actually went into his body because later at 11 :30 pm his blood glucose measured hi on the meter.Wife reported the patient then gave himself a shot of insulin via flex pen; type unknown.Wife stated she then drove the patient to the hospital where his blood glucose reading was 691 mg/dl on the hospital meter.Wife reported they did blood work and then put him on a saline drip and an iv drip of insulin; type of insulin is unknown.Wife stated the patient was admitted to the icu.Wife reported the patient only had symptoms of being thirsty, but no other symptoms of elevated blood glucose level.Wife stated the patient changed to a new cartridge, infusion set and tubing at noon for routine purposes and then at 6:30 pm he change the infusion set because of the elevated blood glucose levels.Wife reported the patient removed the cannula and there was blood that came out with the cannula.Wife stated the patient blames the infusion sets for a possible blockage and the elevated blood glucose levels.Patient is using an inset 30 infusion set manufactured by unomedical and not by our company.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DIABETES INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A DE C.V
• MDR Report Key: 17527287
• MDR Text Key: 321105072
• Report Number: MW5134220
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1