MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® ULTRAFLEX INFUSION SET; SUBCUTANEOUS INFUSION SET

Lot Number ASKU

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 04/10/2016

Event Type  Injury  

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Event Description

It was reported that the patient was hospitalized for hyperglycemia and a heart attack while using the infusion set.It was alleged the hyperglycemia caused from a bent cannula of the infusion set.The patient's blood glucose result was in the "300 mg/dl range" during the event.It is unknown which device produced this result.The patient was treated with insulin via iv.It is unknown how long the patient was in the hospital.The infusion set lot number was not provided.The infusion set is not expected to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® ULTRAFLEX INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): UNOMEDICAL DEVICES S.A. DE C.V; avenida fomento industrial lot; parque industrial del norte; reynosa C.P. 8873; MX C.P. 88736
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7499153
• MDR Text Key: 107748389
• Report Number: 3011393376-2018-01963
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TANDEM INSULIN PUMP; UNKNOWN INSULIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR