MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-02-07 for SYNTHESIS 1715 0001715097 manufactured by Instrumentation Laboratory Co..
[146602]
A customer complaint was received that the il synthesis model 1715 reported an erroneous cohb result of 18% and that the instrument did not flag the error. The quality controls also reported within specification. A site visit by an il field service representative (fsr) showed that the instrument was not being maintained per labeling instructions and as a result a film formed in the cuvette window. Furthermore, cleaning pathway errors had been flagged. After cleaning by the fsr, instrument results returned to normal. Based on a follow-up conversation between the site and the fsr, it was concluded that no pt was treated based on the erroneous cohb result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217183-2000-00001 |
| MDR Report Key | 261680 |
| Report Source | 05 |
| Date Received | 2000-02-07 |
| Date of Report | 2000-02-07 |
| Date of Event | 2000-01-06 |
| Date Mfgr Received | 2000-01-07 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 2000-02-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CAROL MARBLE |
| Manufacturer Street | 113 HARTWELL AVE. |
| Manufacturer City | LEXINGTON MA 02421 |
| Manufacturer Country | US |
| Manufacturer Postal | 02421 |
| Manufacturer Phone | 7818614467 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNTHESIS |
| Generic Name | BLOOD GAS/ELECTROLYTE/GLUCOSE/CO-OXIMETER |
| Product Code | JKS |
| Date Received | 2000-02-07 |
| Model Number | 1715 |
| Catalog Number | 0001715097 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 253432 |
| Manufacturer | INSTRUMENTATION LABORATORY CO. |
| Manufacturer Address | VIALE DELL'INDUSTRIA 3 PADERNO, DUGNANO IT 20037 |
| Baseline Brand Name | SYNTHESIS |
| Baseline Generic Name | BLOOD GAS/ELECTROLYTE/GLUCOSE/CO-OXIMETER |
| Baseline Model No | 1715 |
| Baseline Catalog No | 0001715097 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-02-07 |