CADD-SOLIS WIRELESS COMMUNICATION MODULE
Received Apr 3, 2025 · Event occurred Mar 1, 2025
Report 3012307300-2025-03738 · MDR key 21767324
Device
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D3 - MFR ESTABLISHMENT NAME: CORRECTION. H6. CODES: UPDATED. DEVICE EVALUATION: COMPLAINT FOR THE FAILURE MODE "INTERMITTENT CONNECTIVITY ERROR" COULD NOT BE CONFIRMED AS NO SAMPLES OR PICTURES WERE PROVIDED BY THE CUSTOMER. WITHOUT THE RETURN OF THE SAMPLE(S) A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.
Additional Manufacturer Narrative
E1 - INITIAL REPORTER PHONE: (B)(6). H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS INTERMITTENT CONNECTIVITY WITH THE PUMP DEVICE WHEN IT WAS ATTACHED TO THE AC ADAPTER AND CHARGING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.