MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-27 for NH3L AMMONIA 20766682322 manufactured by Roche Diagnostics.
[58545579]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[58545580]
The customer stated that they received erroneous results for five samples from the same patient tested for nh3l ammonia (nh3) on a c501 analyzer. The results from all 5 samples were reported outside of the laboratory and sent back by the doctor due to not matching the patient's clinical condition. (b)(6). The patient was not adversely affected. The c501 analyzer serial number was (b)(4). When the customer was asked about reagent handling, it was confirmed that the customer did not unscrew a reagent bottle cap and leave the reagent cassette in a dark, covered place for 24 hours prior to placing it on the instrument as instructed in the package insert. The customer was informed that not doing this would result in high ammonia recovery. The customer was informed that the current reagent pack should not be used and that a new reagent cassette should be prepared for use according to the package insert. The customer prepared a new cassette as instructed. Calibration and controls were acceptable with the new cassette. Controls had a slight decrease in recovery for the new cassette versus control recovery for the old cassette that had not been prepared properly. The field service engineer could not determine a cause. He checked probe adjustments, wash pressures, the rinse mechanism, and dry positions. Everything was found to be ok. The customer ran calibration and controls; the results were ok. The customer ran a precision study and this was ok.
Patient Sequence No: 1, Text Type: D, B5
[60115412]
The field service engineer checked special wash programming and this was good. The customer has not experienced any further issues since correctly handling reagent cassettes. Investigations have determined that the issue was solved by correct handling of the reagent cassette. The product was found to meet specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01649 |
| MDR Report Key | 6061132 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-27 |
| Date of Report | 2016-11-07 |
| Date of Event | 2016-10-09 |
| Date Mfgr Received | 2016-10-13 |
| Date Added to Maude | 2016-10-27 |
| 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 | 2016-10-27 |
| Model Number | NA |
| Catalog Number | 20766682322 |
| Lot Number | 15816001 |
| ID Number | NA |
| Device Expiration Date | 2017-11-30 |
| 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 | 2016-10-27 |