FDA Adverse Event
Summary report: N
QUICK CHECK ONE
MDR report key: 90586
·
Received May 9, 1997
Report
- Report Number
- 2027242-1997-90151
- Date Received
- May 9, 1997
- Date of Event
- April 9, 1997
- Report Date
- April 10, 1997
- Manufacturer
- DIAGNOSTIC SOLUTIONS, INC.
- Product Code
- CFR
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH LOT 16089A. ON 4/9/97, THE PATIENT OPENED THE FIRST BOTTLE FROM THE BOX AND OBTAINED A NORMAL CONTROL SOLUTION TEST RESULT OF "190 OR SO" MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 111-167 MG/DL (SOL. LOT UNK, EXP. 9/98). THE PATIENT SHOOK THE CONTROL SOLUTION BEFORE HE APPLIED THE SAMPLE. THE CONTROL SOLUTION WAS OPENED "2 OR MORE" MONTHS AGO. WITH THE CO'S REP, THE PATIENT OBTAINED TWO NORMAL CONTROL SOLUTION TEST RESULTS OF 161 AND 156 MG/DL. THE PATIENT'S METER WAS SET TO THE APPROPRIATE CODE. THE DESICCANT IS IN THE FIRST BOTTLE FROM THE BOX. THE PATIENT HAS NOT OPENED THE SECOND BOTTLE FROM THE SAME BOX. THE PATIENT STORES THE TEST STRIPS IN THE KITCHEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICK CHECK ONE | BLOOD GLUCOSE TEST STRIPS FOR USE WITH ONE TOUCH METERS | CFR | DIAGNOSTIC SOLUTIONS, INC. | * | 16089A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |