MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2004-11-03 for ABL 700 SERIES ABL735 * manufactured by Radiometer Medical Aps.
[20616123]
The instrument reported incorrectly sodium and calcium results too low. No wrong patient treatment was initiated, as the too low value was discovered by using another similar analyzer.
Patient Sequence No: 1, Text Type: D, B5
[20829562]
The cause of the malfunction appears to be usage of the reference membrane for more samples than recommended by the manufacturer. The condition cannot be detected by quality control solutions. After re-membraning of the reference electrode, the measurements were back to normal. Information to all customers regarding reduced lifetime of the reference membrane in case more samples than 70 is done per day, was conveyed in a field action dated october 11, 2002, and the box containing the membranes were affixed a label stating "reduced lifetime. " new action: all customers will be informed again. The labeling will be changed to reflect when the electrode must be re-membraned based on information from investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2004-00006 |
| MDR Report Key | 822056 |
| Report Source | 01,05,06 |
| Date Received | 2004-11-03 |
| Date of Report | 2004-11-03 |
| Date of Event | 2004-10-04 |
| Date Mfgr Received | 2004-10-04 |
| Device Manufacturer Date | 2002-07-01 |
| Date Added to Maude | 2007-03-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LEIF GUDNITZ, CONSULTANT |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Manufacturer Phone | 8273228 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL 700 SERIES |
| Generic Name | BLOODGAS ANALYZER WITH ADDITIONAL PARAMETERS |
| Product Code | CCE |
| Date Received | 2004-11-03 |
| Model Number | ABL735 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 809464 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * DA |
| Baseline Brand Name | ABL735 |
| Baseline Generic Name | BLOOD GAS ANALYSER WITH ADDITIONAL PARAMETERS |
| Baseline Model No | ABL735 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-11-03 |