MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-03-01 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[68767168]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68767169]
The customer complained of erroneous results for 1 patient tested for po2, pco2 and ph on the cobas b 221<6>=roche omni s6 system. At 9:11 p. M. The initial po2 result was 222. 8 mmhg with a data flag, the initial pco2 result was 101. 0 mmhg with a data flag and the initial ph result was 7. 224 with a data flag. At 9:25 p. M. A second sample was obtained and the po2 result was 97. 6 mmhg, the pco2 result was 75. 1 mmhg with a data flag and the ph result was 7. 324 with a data flag. No adverse event occurred. The patient received 3 liters of oxygen. No electrode lot numbers or expiration dates were provided. Based on a review of the calibration and quality control data provided by the customer, no issues were identified. Based on the results of the preliminary investigation, an instrument issue was not identified. The investigation of this issue is ongoing.
Patient Sequence No: 1, Text Type: D, B5
[69978547]
The po2 electrode lot number was 21561947. The pco2 electrode lot number was 21551447. The ph electrode lot number was 21553748.
Patient Sequence No: 1, Text Type: N, H10
[73011112]
The discrepant results were obtained at 9:11 p. M. The patient was tested prior to the discrepant results at 5:16 p. M. And the results were similar to the repeat results at 9:25 p. M. It is unclear what happened to the patient between 5:16 p. M. And 9:11 p. M. If there was a change in the patient's condition or if the patient had been treated, this could have caused the results at 9:11 p. M along with the repeat results at 9:25 p. M. Since the results at 9:25 p. M. Were from a second sample, a storage issue related to the sample and an issue with the type of sampling device can be excluded. A pre-analytic issue cannot be completely excluded however. A case trend analysis showed no further similar complaints. Based on the data provided, the instrument worked correctly and there is no information to suggest the results at 9:11 p. M. Were incorrect. A medical assessment of the event determined that both pco2 results (>70 mmhg) suggest the patient had severe hypercapnia most likely due to an acute exacerbation of copd/respiratory insufficiency. The medical consequence of receiving oxygen therapy or respiratory support would most likely be the same. A product problem was not identified.
Patient Sequence No: 1, Text Type: N, H10
[132589827]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00438 |
| MDR Report Key | 6368875 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-01 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-02-05 |
| Date Mfgr Received | 2017-02-06 |
| Date Added to Maude | 2017-03-01 |
| 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 | ROCHE OMNI S |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2017-03-01 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |