INSET 30
Report
- Report Number
- 3003442380-2025-16881
- Event Type
- Injury
- Date Received
- November 21, 2025
- Date of Event
- November 10, 2025
- Report Date
- January 26, 2026
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018365
- PMA / PMN Number
- K061374
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
SUPPLEMENTAL REPORT 01 - MDR (B)(4)- MDR 3003442380-2025-16881. UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CAPA/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS SUPPLEMENTAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS. A COMPLAINT INVESTIGATION WAS CONDUCTED BASED ON THE EVENT DESCRIPTION AND THE ASSIGNED MALFUNCTION CODE ADHESIVE PATCH COMPLETELY DETACHES DURING USE DETACHMENT SIGNIFICANT WETNESS. ADDITIONAL INFORMATION WAS REQUESTED TO SUPPORT THE INVESTIGATION HOWEVER, A LOT NUMBER INFORMATION WAS NOT PROVIDED. NO DEVICE, DEVICE COMPONENTS, OR OTHER VISUAL OR PHYSICAL EVIDENCE WAS MADE AVAILABLE FOR EVALUATION. CONSEQUENTLY, VISUAL INSPECTION, RETAIN-SAMPLE TESTING, OR THE ASSESSMENT OF POTENTIAL PRODUCT PERFORMANCE ISSUES, COMPONENT INTEGRITY, OR MANUFACTURING DEFECTS COULD NOT BE PERFORMED. IN RESPONSE TO THE COMPLAINT AND DUE TO THE ABSENCE OF A SPECIFIC LOT NUMBER, A HIGH LEVEL INVESTIGATION WAS CONDUCTED FOR THE AUTOSOFT 30 PRODUCT FAMILY AND THE ASSIGNED MALFUNCTION. THE INVESTIGATION INCLUDED AN ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH, ASSESSMENT OF COMPLAINT TRENDS, AND REVIEW OF RELEVANT RISK MANAGEMENT FILES. THE ASSESSMENT OF COMPLAINT DATA FOR THE APPLICABLE PRODUCT FAMILY IDENTIFIED AN ELEVATED TREND FOR THE ASSIGNED MALFUNCTION. HOWEVER, NO NEW CORRECTIVE AND PREVENTIVE ACTION CAPA IS REQUIRED BECAUSE THE ADHESIVE MALFUNCTIONS FALL WITHIN THE SCOPE OF AN EXISTING INVESTIGATION CAPA 2010953. PLEASE REFER TO THE ATTACHED MEMO FOR FULL INVESTIGATION DETAILS: AUTOSOFT 30 ADHESIVE. ENCLOSURE 1: EQMS SEARCH RESULTS . ENCLOSURE 2: MAINTENANCE RESULTS . ENCLOSURE 3: RAW DATA FOR COMPLAINT TRENDING . CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION. BASED ON THE INVESTIGATION, THE ASSESSMENT OF COMPLAINT DATA FOR THE APPLICABLE PRODUCT FAMILY IDENTIFIED AN ELEVATED TREND FOR THE REFERENCED MALFUNCTION. HOWEVER NO NEW CAPA WAS INITIATED BECAUSE THIS MALFUNCTION TYPE IS ALREADY INCLUDED WITHIN THE SCOPE OF AN EXISTING INVESTIGATION, WHICH COVERS ALL INFUSION CARE PORTFOLIO PRODUCTS. NO ADDITIONAL ACTIONS ARE REQUIRED AT THE INDIVIDUAL COMPLAINT LEVEL AT THIS TIME. THE COMPLAINT RECORD WILL BE CLOSED AND CONTINUE TO BE MONITORED THROUGH ROUTINE TRACKING AND TRENDING PER (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS INDIVIDUAL COMPLAINT. COMPLAINT INVESTIGATION - CONCLUSION. DUE TO THE ABSENCE OF A LOT NUMBER AND RETURNED PRODUCT, THE INVESTIGATION WAS LIMITED TO A HIGH LEVEL REVIEW OF THE AUTOSOFT 30 PRODUCT FAMILY, INCLUDING AN EQMS SEARCH, COMPLAINT TRENDING, AND REVIEW OF APPLICABLE RISK MANAGEMENT DOCUMENTATION. COMPLAINT TRENDING FOR THE PRODUCT FAMILY INDICATED AN ELEVATED RATE FOR THE REFERENCED MALFUNCTION. HOWEVER, INITIATION OF A NEW CAPA IS NOT REQUIRED BECAUSE THE ADHESIVE MALFUNCTIONS FALL WITHIN THE SCOPE OF AN EXISTING CAPA 2010953. NO FURTHER ACTION IS REQUIRED AT THE INDIVIDUAL COMPLAINT LEVEL AT THIS TIME. THE RECORD WILL BE CLOSED WITH CONTINUED MONITORING THROUGH ROUTINE TRACKING AND TRENDING PER WORK INSTRUCTION (WI)(MONTHLY TRIPS AND ALERTS). THE RECORD MAY BE REASSESSED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
INITIAL AND FINAL (B)(4) - DEVICE 4 OF 5. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED THE INFUSION SET ADHESIVE ISSUE ON (B)(6) 2025. THE PATIENT REPORTED THAT THE INFUSION SET FELL OFF DURING USE FOR ABOUT 20 MINUTES TO ONE DAY WHICH LEADS TO HIGH BLOOD GLUCOSE LEVELS. THE ISSUE OCCURRED WITH APPROXIMATELY FIVE INFUSION SETS. THE BLOOD GLUCOSE WAS HIGH AND GOT TREATED WITH CORRECTION BOLUS VIA PUMP. THE PATIENT GOT ASSISTANCE FROM MEDICAL PROFESSIONALS AND HOSPITALS. THE PATIENT ALSO TESTED POSITIVE FOR KETONES WHICH WERE DANGEROUS AND LIFE THREATENING. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2076116 | INSET 30 | UNO INSET 30 60/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002825 | UNKNOWN | 05705244018365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Male | Life Threatening |