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

Catalog Number 04626478001

Device Problem Occlusion Within Device (1423)

Patient Problem Hyperglycemia (1905)

Event Date 05/19/2018

Event Type  Injury  

Manufacturer Narrative

The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

The caller reported that there were 4 infusion sets from the same box that were occluding.At an unknown time the patient received an occlusion error.The patient changed the infusion set, but after 2 hours she again received an occlusion error.The patient experienced elevated blood glucose levels and changed the infusion set, transfer set, and cartridge.After two hours her blood glucose level was still elevated and she received another occlusion error.She again changed the infusion set and injected 25 iu of insulin.The patient then left for school.Once at school, the patient received an occlusion error and was not feeling well, the patient experienced elevated blood glucose symptoms.The patient's blood glucose result was "hi" mg/dl on an unknown device.The patient's mother took her to the hospital.The type of treatment provided by the hospital was not provided.It is also unknown how long the patient was hospitalized.The lot number was not provided.The infusion sets were requested to be returned for product evaluation.

Manufacturer Narrative

The cir received five used transfer sets and performed a visual inspection.No abnormalities were detected.Furthermore, a flow and leakage test was performed.Three of the five transfer sets passed the flow and leakage test.An occlusion was found in two transfer sets.The tube was clogged with insulin.The manufacturer tests all products during production for leak and flow.There is no indication that a nonspecific product has been delivered to any customer.

• Brand Name: ACCU-CHEK ® FLEXLINK 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: 7570543
• MDR Text Key: 110119275
• Report Number: 3011393376-2018-02321
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04626478001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Outcome(s): Hospitalization
• Patient Age: 16 YR
• Patient Weight: 70