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 2013-04-29 for COBAS B 221<6>=ROCHE OMNI S6 SYSTEM 03337154001 manufactured by Roche Diagnostics.
[10733917]
Databases received from the customer show quality controls were within range. Calibration values were also acceptable. Comparison measurements with a retention sample of lot 25124850 were performed and were within specification. Batch records were reviewed and no abnormalities were found. A quality issue could not be verified with mss-g/l/u sensor lot 21524850. The customer also measures fluoride samples. Data provided showed higher signals at the interference sensor which indicates use of an unsuitable anticoagulant. Labeling indicates that the only clot inhibitors that may be used for analyses on the cobas b221 system are heparin salts. Other clot inhibitors, such as fluoride have significant influence on blood's ph and other parameters.
Patient Sequence No: 1, Text Type: N, H10
[11493754]
Medwatch (manufacturing site) was updated.
Patient Sequence No: 1, Text Type: N, H10
[15017874]
The customer reported that they received an erroneous result for one patient sample tested for glucose. The capillary sample initially resulted as 3. 3 mmol/l and this value was reported outside of the laboratory. A fluoride sample from the same patient was tested on the laboratory chemistry analyzer and this sample resulted with a glucose value of 1. 7 mmol/l which was reported to the ward. The customer was not sure of the timing of the fluoride sample and how close it was to the measurement of the capillary sample. A sample from the patient was also tested on an inform ii meter and this resulted as 1. 9 mmol/l. It is unknown if the sample tested on the inform ii meter is the same capillary sample that was initially tested or if it was a different sample. Treatment for hypoglycemia was delayed for the patient as a result of the issue. The patient received treatment after the laboratory result of 1. 7 mmol/l was received by the ward. The patient was not adversely affected by the event. The lot number of the glucose/lactate cassette was 21524850. The expiration date was not provided.
Patient Sequence No: 1, Text Type: D, B5
[15280358]
This event occurred in the (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21309192]
The date received by manufacturer is (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-02587 |
| MDR Report Key | 3081707 |
| Report Source | 01,05,06 |
| Date Received | 2013-04-29 |
| Date of Report | 2014-02-03 |
| Date of Event | 2013-03-07 |
| Date Mfgr Received | 2013-04-05 |
| Date Added to Maude | 2013-04-29 |
| 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 | 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 | COBAS B 221=ROCHE OMNI S6 SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2013-04-29 |
| 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 | 2013-04-29 |