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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number 5351323
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Hyperglycemia (1905)
Event Date 04/16/2022
Event Type  Injury  
Event Description
The caller reported that on (b)(6) 2022 the self-adhesive of the infusion set was not sticking well enough, and did not adhere to the customer's body. The customer was traveling and did not have any more infusion sets with them. The user experienced an elevated blood glucose result of 290 mg/dl and used back up pen therapy to administer insulin. The customer was traveling and was unable to obtain new infusion sets and had been without pump therapy for 20 hours. On (b)(6) 2022 the customer went to the hospital for high blood glucose levels. The customer was admitted into the hospital for four hours and was treated with lantus insulin to stabilize blood glucose.
 
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. Product was discarded and no longer available to be returned.
 
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Brand NameACCU-CHEK ® FLEXLINK INFUSION SET
Type of DeviceSUBCUTANEOUS 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
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key14251471
MDR Text Key290400253
Report Number3011393376-2022-01298
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number5351323
Was Device Available for Evaluation? No
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2021
Is the Device Single Use? Yes
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN PEN
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