SURELIFE
Report
- Report Number
- 3005798905-2024-03192
- Event Type
- Injury
- Date Received
- July 16, 2024
- Date of Event
- July 12, 2024
- Report Date
- July 15, 2024
- Manufacturer
- TRULY INSTRUMENT CO. LTD
- Product Code
- DXN
- PMA / PMN Number
- K091434
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
INITIAL TREND ANALYSIS FOR LOT 57613 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 57613. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
INITIAL TREND ANALYSIS FOR LOT 57613 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 57613. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
THE AFFECTED DEVICE WAS RETURNED TO THE CMO ON 07-25-2024 AND TESTED FOR ANY IRREGULARITIES PER THE COMPLAINT REPORTED. NO ABNORMALITIES WERE FOUND DURING TESTING OF THE PRODUCT, NO PRODUCT PROBLEM FOUND.
END USER REPORTS RECEIVING ERRATIC AND FALSE HIGH READINGS WHILE USING THE SURELIFE CLASSIC ARM BLOOD PRESSURE MONITOR (860213) LOT 57613. AFTER WAKING, TAKING BLOOD PRESSURE MEDICATION THE USER TOOK A READING A FEW HOURS LATER RECEIVING 131/111, RETESTED AND RECEIVED ANOTHER READING WITH THE DIASTOLIC OVER 100. USER STATES THAT A BLOOD PRESSURE READING OF 120/80 IS "NORMAL" FOR THEM. AFTER TAKING ANOTHER READING AND RECEIVING A READING WITH THE DIASTOLIC OVER 100, THE USER DROVE THEMSELF TO THE HOSPITAL AND WAS SEEN IN THE EMERGENCY ROOM RIGHT AWAY AND WAS TESTED FOR HIGH BLOOD PRESSURE. OVER THE COURSE OF A 6 HOUR STAY AT THE HOSPITAL THE USER WAS TESTED WITH A HOLTER MONITOR, X-RAY AND A BLOOD DRAW. ALL TESTING RESULTS WERE NORMAL. USER THEN ARRIVED HOME AND TESTED AGAIN USING THE SURELIFE CLASSIC ARM BLOOD PRESSURE MONITOR (860213) LOT 5761 AND AGAIN GOT A HIGH READING OF 148/129. USER WENT TO TRY TO RETURN THE BPM TO HIS PHARMACY AND AFTER USED THE PHARMACY'S BLOOD PRESSURE MONITOR AND RECEIVED A READING OF 137/77.
END USER REPORTS RECEIVING ERRATIC AND FALSE HIGH READINGS WHILE USING THE SURELIFE CLASSIC ARM BLOOD PRESSURE MONITOR (860213) LOT 57613. AFTER WAKING, TAKING BLOOD PRESSURE MEDICATION THE USER TOOK A READING A FEW HOURS LATER RECEIVING 131/111, RETESTED AND RECEIVED ANOTHER READING WITH THE DIASTOLIC OVER 100. USER STATES THAT A BLOOD PRESSURE READING OF 120/80 IS "NORMAL" FOR THEM. AFTER TAKING ANOTHER READING AND RECEIVING A READING WITH THE DIASTOLIC OVER 100, THE USER DROVE THEMSELVES TO THE HOSPITAL AND WAS SEEN IN THE EMERGENCY ROOM RIGHT AWAY AND WAS TESTED FOR HIGH BLOOD PRESSURE. OVER THE COURSE OF A 6 HOUR STAY AT THE HOSPITAL THE USER WAS TESTED WITH A HOLTER MONITOR, X-RAY AND A BLOOD DRAW. ALL TESTING RESULTS WERE NORMAL. USER THEN ARRIVED HOME AND TESTED AGAIN USING THE SURELIFE CLASSIC ARM BLOOD PRESSURE MONITOR (860213) LOT 5761 AND AGAIN GOT A HIGH READING OF 148/129. USER WENT TO TRY TO RETURN THE BPM TO HIS PHARMACY AND AFTER USED THE PHARMACY'S BLOOD PRESSURE MONITOR AND RECEIVED A READING OF 137/77.
END USER REPORTS RECEIVING ERRATIC AND FALSE HIGH READINGS WHILE USING THE SURELIFE CLASSIC ARM BLOOD PRESSURE MONITOR (860213) LOT 57613. AFTER WAKING, TAKING BLOOD PRESSURE MEDICATION THE USER TOOK A READING A FEW HOURS LATER RECEIVING 131/111, RETESTED AND RECEIVED ANOTHER READING WITH THE DIASTOLIC OVER 100. USER STATES THAT A BLOOD PRESSURE READING OF 120/80 IS "NORMAL" FOR THEM. AFTER TAKING ANOTHER READING AND RECEIVING A READING WITH THE DIASTOLIC OVER 100, THE USER DROVE THEMSELF TO THE HOSPITAL AND WAS SEEN IN THE EMERGENCY ROOM RIGHT AWAY AND WAS TESTED FOR HIGH BLOOD PRESSURE. OVER THE COURSE OF A 6 HOUR STAY AT THE HOSPITAL THE USER WAS TESTED WITH A HOLTER MONITOR, X-RAY AND A BLOOD DRAW. ALL TESTING RESULTS WERE NORMAL. USER THEN ARRIVED HOME AND TESTED AGAIN USING THE SURELIFE CLASSIC ARM BLOOD PRESSURE MONITOR (860213) LOT 5761 AND AGAIN GOT A HIGH READING OF 148/129. USER WENT TO TRY TO RETURN THE BPM TO HIS PHARMACY AND AFTER USED THE PHARMACY'S BLOOD PRESSURE MONITOR AND RECEIVED A READING OF 137/77.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2523826 | SURELIFE | BLOOD PRESSURE MONITOR | DXN | TRULY INSTRUMENT CO. LTD | 57613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |