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 2017-06-02 for NH3L AMMONIA 20766682322 manufactured by Roche Diagnostics.
[76524578]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76524579]
The customer complains that they receive consistently high results for two patients tested for nh3l ammonia (nh3) on a cobas integra 800 (i800) analyzer. Both patients are children with a rare metabolic syndrome, argininosuccinic aciduria. The children's parents stated that the nh3 results were consistently higher after the laboratory switched to using the roche nh3 assay. There was no change in the children's health or dietary status. The children have been on a fixed diet regime since the diagnosis of the metabolic syndrome. Previous results from these patients with the siemens method were consistently within the normal range. The customer provided data for one of the two patients. A sample from this patient had an erroneous nh3 value that was reported outside of the laboratory to the parents and treating physician. The sample resulted as 87 umol/l when tested with the roche nh3 assay on the i800 analyzer. After this, the parents decided to take the child to another laboratory for testing. At the other laboratory, a new sample was collected from the patient a couple hours later on the same day and tested on a siemens analyzer. The result from the siemens analyzer was 32 umol/l. No adverse events were alleged to have occurred with the patient. The i800 analyzer serial number was (b)(4). For troubleshooting, the customer collected a sample from one of the laboratory personnel and tested it in parallel on the i800 analyzer and cobas 6000 c (501) module. The nh3 results from this sample were comparable.
Patient Sequence No: 1, Text Type: D, B5
[120146877]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. A sample from the patient was provided for investigation. The customer's result could not be reproduced during the investigation due to the high lipemia index of the sample. No accurate results could be generated from the sample due to high turbidity. The customer did not measure the serum indices of the sample, so turbidity of the sample at the time of measurement at the customer site could not be excluded. A hardware or reagent issue could be excluded since calibration was successful and quality controls were within range. Also, the serum collected and tested from the laboratory personnel was within the normal range.
Patient Sequence No: 1, Text Type: N, H10
[132595090]
The package insert for the nh3l ammonia assay on the cobas integra 800 states there is no significant interference up to an l index (lipemia index) of 80. The l index of the patient sample submitted for investigation was 574. Due to the extremely high turbidity of the sample, an ammonia result could not be obtained during investigation. The customer did not measure the l index of their samples before testing. Based on the available information and the results of the sample that was investigated, a high l index is the likely cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01133 |
| MDR Report Key | 6607569 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-02 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-05-17 |
| Date Added to Maude | 2017-06-02 |
| 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 | 2017-06-02 |
| Model Number | NA |
| Catalog Number | 20766682322 |
| Lot Number | 16755701 |
| 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 | 2017-06-02 |