IHEALTH
Report
- Report Number
- 3003741676-2025-00004
- Event Type
- Malfunction
- Date Received
- November 27, 2025
- Date of Event
- October 2, 2025
- Report Date
- December 4, 2025
- Manufacturer
- ANDON HEALTH CO., LTD.
- Product Code
- NBW
- PMA / PMN Number
- K181070
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
1.FOLLOWED UP MULTIPLE TIMES, WE HOPE TO OBTAIN THE BATCH NUMBER OF THE TEST STRIPS USED, THE CONTROL SOLUTION TEST RESULTS, AND RETURN THE ABNORMAL EQUIPMENT FOR FURTHER ANALYSIS, BUT HAVE NOT RECEIVED A REPLY FROM THE USER. ON (B)(6), A REPLACEMENT DEVICE WAS SENT TO THE USER, AND ASK IF IT IS WORKING PROPERLY, BUT NO REPLY WAS RECEIVED. 2.DUE TO THE INABILITY TO OBTAIN MORE ANALYZABLE INFORMATION SUCH AS DEVICE AND TEST STRIP DETAILS, THE CAUSE OF THE READING DISCREPANCY CANNOT BE DETERMINED. 3.AFTER VERIFICATION, THE PRODUCTION AND INSPECTION RECORDS OF THE BLOOD GLUCOSE METER AND SUPPORTING TEST STRIPS (LOT NUMBER: 2100000362/241031206) HAVE BEEN CONFIRMED TO MEET THE SPECIFICATIONS. 4.NO SERIOUS INJURIES WERE REPORTED IN THIS INCIDENT, BUT THE ELEVATED RESULTS HAVE LED TO MEDICAL INTERVENTION. THERE IS A POTENTIAL RISK OF ADVERSE HEALTH EFFECTS IF IT OCCURS AGAIN, SO THIS REPORT IS EVALUATED AND SUBMITTED. 5.IF ADDITIONAL USER INFORMATION OR OTHER RELEVANT EVIDENCE IS OBTAINED IN THE FUTURE, THE INVESTIGATION WILL CONTINUE AND THE REPORT WILL BE UPDATED.
FOLLOWED UP MULTIPLE TIMES, WE HOPE TO OBTAIN THE BATCH NUMBER OF THE TEST STRIPS USED, THE CONTROL SOLUTION TEST RESULTS, AND RETURN THE ABNORMAL EQUIPMENT FOR FURTHER ANALYSIS, BUT HAVE NOT RECEIVED A REPLY FROM THE USER. ON (B)(6), A REPLACEMENT DEVICE WAS SENT TO THE USER, AND ASK IF IT IS WORKING PROPERLY, BUT NO REPLY WAS RECEIVED. DUE TO THE INABILITY TO OBTAIN MORE ANALYZABLE INFORMATION SUCH AS DEVICE AND TEST STRIP DETAILS, THE CAUSE OF THE READING DISCREPANCY CANNOT BE DETERMINED. AFTER VERIFICATION, THE PRODUCTION AND INSPECTION RECORDS OF THE BLOOD GLUCOSE METER AND SUPPORTING TEST STRIPS (LOT NUMBER: 2100000362/241031206) HAVE BEEN CONFIRMED TO MEET THE SPECIFICATIONS. NO SERIOUS INJURIES WERE REPORTED IN THIS INCIDENT, BUT THE ELEVATED RESULTS HAVE LED TO MEDICAL INTERVENTION. THERE IS A POTENTIAL RISK OF ADVERSE HEALTH EFFECTS IF IT OCCURS AGAIN, SO THIS REPORT IS EVALUATED AND SUBMITTED. IF ADDITIONAL USER INFORMATION OR OTHER RELEVANT EVIDENCE IS OBTAINED IN THE FUTURE, THE INVESTIGATION WILL CONTINUE AND THE REPORT WILL BE UPDATED. THE REVISED CONTENT OF THE FOLLOW-UP REPORT IS AS FOLLOWS: MODIFY THE PRODUCT CODE TO NBW, AND FILL IN THE 510(K) SUBMISSION NUMBER K181070.
ACCORDING TO CUSTOMER FEEDBACK, THE READINGS MEASURED USING THE IHEALTH BLOOD GLUCOSE METER WERE TOO HIGH (DESCRIBED AS RANGING FROM 300-400MG/DL), LEADING HIS DOCTOR TO DOUBLE THE MEDICATION DOSAGE.HOWEVER, WHEN USING ANOTHER BRAND OF BLOOD GLUCOSE METER, THE READING WAS 158 MG/DL.
ACCORDING TO CUSTOMER FEEDBACK, THE READINGS MEASURED USING THE IHEALTH BLOOD GLUCOSE METER WERE TOO HIGH (DESCRIBED AS RANGING FROM 300-400MG/DL), LEADING HIS DOCTOR TO DOUBLE THE MEDICATION DOSAGE.HOWEVER, WHEN USING ANOTHER BRAND OF BLOOD GLUCOSE METER, THE READING WAS 158 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2136171 | IHEALTH | RADIORECEPTOR ASSAY, HUMAN CHORIONIC GONADOTROPIN | NBW | ANDON HEALTH CO., LTD. | BG5S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |