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 2018-03-14 for NH3L AMMONIA C501 20766682322 manufactured by Roche Diagnostics.
[103010519]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103010520]
The customer stated that they received questionably high results for an unspecified number of patient samples tested for nh3l ammonia (nh3) on a cobas 6000 c (501) module - c501. Samples will repeat in normal ranges. The customer provided data for one patient sample which had an erroneous nh3 result that was reported outside of the laboratory. The sample initially resulted as 193. 5 ug/l. The value was reported outside of the laboratory to the doctor, who asked for a rerun of the sample since the value was not compatible with the patient's clinical history. The sample was repeated on the same analyzer, resulting as 33. 1 ug/dl. The sample was also repeated on a second c501 analyzer, resulting as 30. 6 ug/l. No adverse events were alleged to have occurred with the patient. The nh3 reagent lot number was 273314, with an expiration date of 31-mar-2019. The last calibration performed on (b)(6) 2018 was flagged with an error. Quality control recovery was not stable, but was within range on the date of the event. Several abnormal probe aspiration alarms occurred on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00823 |
| MDR Report Key | 7337229 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-14 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-02-28 |
| Date Added to Maude | 2018-03-14 |
| 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 | 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 | NH3L AMMONIA |
| Generic Name | ENZYMATIC METHOD, AMMONIA |
| Product Code | JIF |
| Date Received | 2018-03-14 |
| Model Number | C501 |
| Catalog Number | 20766682322 |
| Lot Number | 273314 |
| ID Number | NA |
| Device Expiration Date | 2019-03-31 |
| 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 | 2018-03-14 |