AUTOSOFT 90
Report
- Report Number
- 3003442380-2025-07123
- Event Type
- Malfunction
- Date Received
- April 25, 2025
- Date of Event
- February 1, 2025
- Report Date
- October 13, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244018303
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL AND FINAL MDR (B)(4) -DEVICE 1 OF 2.
SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-07123. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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: PER REVISION 21 OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DHR REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001947, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001947 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 105 AND MANUFACTURED IN THE LINE L4 ON 25-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.
REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. THIS MDR IS BEING SUBMITTED FOR AN UNKNOWN QUANTITY OF INFUSION SETS THAT HAD THE REPORTED ISSUE. THE PATIENT REPORTED AN INCIDENT INVOLVING THEIR INFUSION SET, SPECIFICALLY NOTING A BENT NEEDLE DURING THE INSERTION PROCESS EVENT ON (B)(6) 2025. AS A RESULT OF THIS ISSUE, THE PATIENT'S BLOOD GLUCOSE LEVEL INCREASED SIGNIFICANTLY, ALTHOUGH THE EXACT VALUE WAS NOT KNOWN. THE PATIENT'S GLUCOSE MONITORING DEVICE SIMPLY DISPLAYED 'HIGH', INDICATING AN ELEVATED BLOOD GLUCOSE LEVEL. TO ADDRESS THIS HIGH BLOOD GLUCOSE SITUATION, THE PATIENT TOOK PROMPT ACTION BY ADMINISTERING A CORRECTION DOSE OF INSULIN USING A MULTIPLE DAILY INJECTION (MDI) METHOD. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1227568 | AUTOSOFT 90 | UNO INSET II 60/6 BLUE TCAP 10PK INT | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | 1002823 | 6001947 | 05705244018303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Male |