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 2018-02-02 for COBAS B 123 <4> SYSTEM 05122287001 manufactured by Roche Diagnostics.
[99775257]
This event occurred in (b)(6). (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[99775258]
The customer stated that they received erroneous results for one patient tested for total hemoglobin (thb) and hematocrit (hct) on a cobas b 123 poc system (b123). The sample was run in capillary mode and initially resulted with a thb value of 4. 8 g/dl and a hct value of 19. 7 %. The same sample was repeated on a second analyzer in syringe mode and resulted with a thb value of 10. 2 g/dl and a hct value of 33. 0 %. The results from the second analyzer were believed to be correct. No adverse events were alleged to have occurred with the patient. The sensor cartridge lot number and expiration date were asked for, but not provided. The customer states that they may not have mixed the sample correctly when performing initial testing. Similar issues did not occur with subsequent samples and the customer has not encountered any further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00324 |
| MDR Report Key | 7237932 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-02 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-01-19 |
| Date Mfgr Received | 2018-01-19 |
| Date Added to Maude | 2018-02-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 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 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 | COBAS B 123 SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | GKR |
| Date Received | 2018-02-02 |
| Model Number | NA |
| Catalog Number | 05122287001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS B 123 SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | CHL |
| Date Received | 2018-02-02 |
| Model Number | NA |
| Catalog Number | 05122287001 |
| 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 | 2018-02-02 |