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 2005-10-10 for BLOODGAS ANALYZER ABL735 * manufactured by Radiometer Medical Aps.
[414594]
Radiometer received the following complaint from our german distributor on 09/2005 at 8:38 in the morning: we received information from our technician about problems on measurement of the parameter ph on the analyzer abl725. He reported that her doctor called from the hospital called him and described the following situation: last night they had a faulty measurement on parameter ph. The blood sample was taken from a neonate and the parameter was clearly too low. The baby is female born in 09/2005 (week gestation 37) birth weights 3700g, with the admission diagnosis spesis with pulmonary-involvement. The new born was buffered with 12mmol sodium bicarbonate. After that, one of the doctors took a blood sample from himself and his measure value for ph was so low that he normally should be admitted to intensive care unit. Half an hour later, the measured values were back to normal. It was reported that the problem with too low measured ph values had appeared several times the last months. Unfortunately, the customer did not measure qc's in this regard. The analyzer did not show any error messages while measuring too deep on ph and also no error messages on calibrations. Our technician replaced the ph electrode (e777; lot pl-02) with a new one. The ref-electrode (e1001;lot 49-5) is still placed in the analyzer. The concerned electrode is on theway back to us. On september doctor was asked about the condition of the baby and he answered that the neonate has not been harmed and the current status of the baby is absolutely fine.
Patient Sequence No: 1, Text Type: D, B5
[433029]
A blood sample was taken from a patient and the reported ph value was very low. The doctor treated the patient according to the measured ph-values without therapeutic success. After that, a new sample from a healthy adult was measured; this gave the same low ph value. Half an hour later, the reported values were back to normal. The site has reported that the problem with too low ph values had appeared several times over the last months. The customer did not use qc's in this case. The analyzer did not show any error messages while measuring too low on ph or any error messages on calibrations. No adverse outcome, the patient is reported in fine health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2005-00010 |
| MDR Report Key | 640527 |
| Report Source | 01,05,06 |
| Date Received | 2005-10-10 |
| Date of Report | 2005-10-06 |
| Date of Event | 2005-09-06 |
| Date Mfgr Received | 2005-09-06 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 2005-10-14 |
| 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 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOODGAS ANALYZER |
| Generic Name | ABL735 |
| Product Code | CCE |
| Date Received | 2005-10-10 |
| Model Number | ABL735 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 630036 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| 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. Other | 2005-10-10 |