• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE; SPRING LOADED INSERTION DEVICE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIABETES CARE, INC. ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE; SPRING LOADED INSERTION DEVICE Back to Search Results
Catalog Number 05511097001
Device Problem Difficult to Insert (1316)
Patient Problem Hyperglycemia (1905)
Event Date 08/15/2022
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
It was reported that the insertion device didn't insert the cannulas correctly, as the customer's blood glucose levels elevate when she uses this insertion device.On (b)(6) 2022, a few hours after using the insertion device, the customer's blood glucose level was reading hi (= higher than the measurement range of the meter) on her meter.She also had ketone bodies (amount unknown).The patient went to hospital where she was treated with a drip.She stayed in the hospital for 7.5 hours before her blood glucose levels returned to normal and she was allowed to go home.The customer also noticed that after using the device the cannula looked bent.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE
Type of Device
SPRING LOADED INSERTION DEVICE
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
BALDA MEDICAL GMBH & CO. KG
bergkichener str. 228
na
bad oeynhausen 32549
GM   32549
Manufacturer Contact
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key15869511
MDR Text Key304356768
Report Number3011393376-2022-03491
Device Sequence Number1
Product Code KZH
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/01/2022
Device Catalogue Number05511097001
Device Lot Number1702
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/21/2022
Initial Date FDA Received11/28/2022
Supplement Dates Manufacturer Received01/24/2023
04/11/2023
Supplement Dates FDA Received01/25/2023
04/11/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age60 YR
Patient SexFemale
-
-