MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-10-28 for CLINITEK 50 ANALYZER manufactured by Bayer Corp..
[16533681]
Customer reported a discrepant result for ph between a clinitek 50 instrument and a ph probe. Patient was a chemotherapy patient treated with methoxotrate. No unnecessary medical procedure was performed. No treatment was withheld as a result of this incident. There was no impact to patient health.
Patient Sequence No: 1, Text Type: D, B5
[16569937]
Manufacturer believes it is likely that a metabolite of the methotrexate caused a reaction with the methyl red in the multistix ph reagent which resulted in the ph reagent indicating that the sample was acidic. The ph meter would not have been effected and would have provided the correct result. Customer reported that the reagent and instrument worked fine with qc material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00039 |
| MDR Report Key | 2325988 |
| Report Source | 07 |
| Date Received | 2011-10-28 |
| Date of Report | 2011-09-30 |
| Date of Event | 2011-09-29 |
| Date Mfgr Received | 2011-09-30 |
| Date Added to Maude | 2012-07-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARH SMITH |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693158 |
| Manufacturer G1 | BAYER CORP. |
| Manufacturer Street | 1884 MILES AVE. |
| Manufacturer City | ELKHART IN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK 50 ANALYZER |
| Generic Name | CLINITEK 50 ANALYZER |
| Product Code | JHJ |
| Date Received | 2011-10-28 |
| Model Number | CLINITEK 50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER CORP. |
| Manufacturer Address | 1884 MILES AVE. ELKHART IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-28 |