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 |