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 2017-04-25 for ACETAMINOPHEN 20767174160 manufactured by Roche Diagnostics.
[73614467]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73614468]
The customer received questionable high aceta acetaminophen results for multiple samples from one patient beginning on (b)(6) 2017. The samples were tested on two cobas 6000 c 501 module analyzers at the site and the results did not fit the clinical picture of the patient. On (b)(6) 2017: 122. 5 ug/ml. On (b)(6) 2017: 115 ug/ml. The doctor had this sample sent out for repeat testing. The result from the reference laboratory using hplc was < 10 ug/ml. The customer did not know which result was correct. On (b)(6) 2017: 106. 8 ug/ml. On (b)(6) 2017: 102. 6 ug/ml. On (b)(6) 2017: 98. 2 ug/ml. On (b)(6) 2017: 93. 5 ug/ml. All of the results were reported outside of the laboratory. The patient was admitted to the hospital based on the high result from (b)(6) 2017 and was then treated each day from (b)(6) 2017 with acetyl cysteine for acetaminophen overdose. The patient was discharged on (b)(6) 2017 to a skilled nursing facility. The patient's current status was given as "well enough for discharge". The patient was not adversely affected by the treatment received. The serial number for one of the c501 analyzers was (b)(4). The serial number for the second c501 analyzer was requested but not provided. The customer stated the qc results have been acceptable and they have not had issues with other patient samples. The customer declined a service visit as they believe this is an issue with patient sample and the assay.
Patient Sequence No: 1, Text Type: D, B5
[76173951]
Four samples from the patient were submitted for investigation and the customer's high results were reproduced. The samples were tested with the acetaminophen gen 2 reagent. The results were negative and were comparable to the hplc result. Due to the difference between the two reagents, an interfering factor was suspected. The samples were then tested with the acetaminophen reagent with a 1:2 dilution and the results confirmed interference. As described in product labeling, other substances and/or factors may interfere with acetaminophen assay and cause unreliable results. A general reagent issue was not found.
Patient Sequence No: 1, Text Type: N, H10
[132583011]
Additional information was provided that the patient's diagnosis was dementia and the liver function was normal. The acetyl cysteine dosage information was provided. Refer to the attachment to the medwatch. A specific root cause could not be determined. All medications taken by the patient (bumetanide, donepezil, quetiapine, sertraline, and tamsulosin) were tested for possible interference, but did not show any interference with concentrations of 5x the daily dose (toxic concentration).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00882 |
| MDR Report Key | 6518857 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-25 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-04-04 |
| Date Added to Maude | 2017-04-25 |
| 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 | 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 | ACETAMINOPHEN |
| Generic Name | COLORIMETRY, ACETAMINOPHEN |
| Product Code | LDP |
| Date Received | 2017-04-25 |
| Model Number | NA |
| Catalog Number | 20767174160 |
| Lot Number | 18036001 |
| 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 | 2017-04-25 |