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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK SPIRIT TENDERLINK INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Injection Site Reaction (4562)
Event Date 02/01/2020
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. Product is no longer available to be returned for evaluation.
 
Event Description
The caller reported that he was hospitalized twice due to an abscess/hematoma formation from wearing the infusion set. The caller reported the first hospitalization was in (b)(6) of 2020. He stated he received 5 surgical operations to remove the abscess and spent 2 weeks in inpatient care. The date of the 2nd hospitalization is unknown. The customer also reported receiving a surgical operation to remove an abscess and was hospitalized for 2 days for this event.
 
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Brand NameACCU-CHEK SPIRIT TENDERLINK 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 A/S
aaholmvej 1 - 3
na
osted 4320
DA 4320
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key11084105
MDR Text Key224027130
Report Number3011393376-2020-04653
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeNULL
Event Location No Information
Date Manufacturer Received12/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 12/28/2020 Patient Sequence Number: 1
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