MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-05-21 for OMNI 03337154001 manufactured by Roche Diagnostics.
[5820945]
The customer from a neonatal department complained of a difference for multiple tests between values obtained from 2 capillary heel sticks and a venous sample for one patient sample. Based on the information provided, erroneous so2 results were reported outside of the laboratory. The initial so2 result from a heel stick was 92. 7%. The repeat heel stick result was 87. 6%. The venous result was 70. 9% with a data flag. The heel stick results were reported outside of the laboratory. The venous result was considered to be correct. No adverse event was reported. The reagent lot numbers and expiration dates were not provided.
Patient Sequence No: 1, Text Type: D, B5
[13297382]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[28325512]
A specific root cause could not be identified. The most likely root cause is related to pre-analytics. No product malfunction was found.
Patient Sequence No: 1, Text Type: N, H10
[32300325]
Based on further investigation, there is a strong indication of a general sample related issue. When comparing the so2 values reported for the two samples (92. 7% and 87. 6%) to their corresponding po2 value (60. 0 mm hg & 55. 1 mm hg), the measured sample had a different so2 value. For both tests, the second sample had significantly decreased values. The po2 is measured with a different measurement technique in a different location in the analyzer from the so2. Therefore it is likely the two samples had different so2 values. An instrument related problem was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03510 |
| MDR Report Key | 4788555 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-05-21 |
| Date of Report | 2018-04-04 |
| Date of Event | 2015-04-19 |
| Date Mfgr Received | 2015-05-05 |
| Date Added to Maude | 2015-05-21 |
| 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 | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNI |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2015-05-21 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-21 |