MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-03-30 for RAPIDPOINT 400 109824 manufactured by Chiron Diagnostics Corp..
[129910]
Customer reported under-recovery of rapidqc complete quality control material for partial oxygen pressure results. Level 1 : assigned range 134-156 mmhg; values obtained 126/127/130 mmhg; level 2: assigned range 88-104; values obtained 83/85/97; level 3: assigned range 12-34; values obtained 21/22. This indicated that there was potential for under-reporting pt values for partial pressure of oxygen. It is believed that no pt data was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-1999-00001 |
| MDR Report Key | 217100 |
| Report Source | 05 |
| Date Received | 1999-03-30 |
| Date of Report | 1999-03-01 |
| Date of Event | 1999-03-01 |
| Date Mfgr Received | 1999-03-01 |
| Date Added to Maude | 1999-04-06 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDPOINT 400 |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | CCC |
| Date Received | 1999-03-30 |
| Model Number | NA |
| Catalog Number | 109824 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 210584 |
| Manufacturer | CHIRON DIAGNOSTICS CORP. |
| Manufacturer Address | 63 NORTH ST. MEDFIELD MA 020521688 US |
| Baseline Brand Name | RAPIDPOINT 400 |
| Baseline Generic Name | BLOOD GAS ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 109824 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-03-30 |