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 2013-06-28 for OMNI B221 03337154001 manufactured by Roche Diagnostics.
[3470482]
The customer stated the analyzer produced an arterial blood gas report on a patient and sent the results to the lis. The intensive care doctor contacted the laboratory because the results did not match previous results or fit the patient's clinical picture. It was then discovered the patient had not had a sample drawn at that time. Further investigation by the customer determined the analyzer produced another blood gas report on another patient with the identical time stamp. The customer stated these results were not stored in the analyzer, nor were they transmitted to the lis, but that they were correct results for that patient. The results that were incorrectly reported on the first patient were: ph = 7. 335 pco2 = 5. 64 kpa po2 = 23. 01 kpa so2 = 99. 2% beecf = -3. 8 mmol/l na+ = 140. 7 mmol/l k+ = 3. 80 mmol/l cl- = 104. 6 mmol/l ca2+ = 1. 216 mmol/l hct(c) = 0. 415 cohb = 0. 011 methb = 0. 007 glu = 6. 2 mmol/l lac = 1. 4 mmol/l there were no adverse events.
Patient Sequence No: 1, Text Type: D, B5
[10923555]
The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[10984756]
Sex has been updated. The serial number of the device is (b)(4) the patient's current condition is stable. The investigation determined it is possible to generate two printouts with the same timestamp but different patient ids. The nurse involved in the event was interviewed. He stated, the name change was done while the measurement workflow was running. He stated, he used the "last patients" function and most likely accidently picked the wrong patient from the list.
Patient Sequence No: 1, Text Type: N, H10
[11493757]
Medwatch (manufacturing site) was updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-03937 |
| MDR Report Key | 3196117 |
| Report Source | 01,05,06 |
| Date Received | 2013-06-28 |
| Date of Report | 2014-02-03 |
| Date of Event | 2013-05-28 |
| Date Mfgr Received | 2013-06-03 |
| Date Added to Maude | 2013-06-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNI B221 |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2013-06-28 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | NURSE |
| 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 | 2013-06-28 |