MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-21 for ELECSYS ACTH TEST SYSTEM 03255751190 manufactured by Roche Diagnostics.
[60866691]
(b)(4). The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[60866692]
The customer alleged questionable results for multiple samples from one patient tested with the elecsys acth test system on a cobas 6000 e 601 module. The serial number of the e 601 module was requested but not provided. Refer to the attachment to this mdr for all data. The physician asked for an investigation because he believed the acth results were unexpectedly elevated. The results have been high independent of steroids, cortisol, or an acth loading test. The elecsys acth results did not change with dilution. The patient was not adversely affected by the results.
Patient Sequence No: 1, Text Type: D, B5
[62576215]
The customer sent 4 samples from the patient to the manufacturer. Testing by the manufacturer reproduced the customer's results. Preliminary investigations indicate a possible non-specific igm antibody in the samples. Investigation of the samples is ongoing. The unit of measure for cortisol was initially reported as ug/ml. The customer has provided new information that the unit of measure is actually ug/dl.
Patient Sequence No: 1, Text Type: N, H10
[67340807]
The following medical background and additional test results were provided for the patient: this patient has been diagnosed as adrenal insufficiency caused by medical treatment. The patient was initially analyzed as membranous nephropathy and treated with prednisolone in 2014. In 2015, after reduction of dose, the patient had started feeling feebleness and adrenal insufficiency was suspected. With increase of prednisolone, the patient's condition got better. Based on results of renin and aldosterone (normal values), the physician diagnosed her as adrenal insufficiency caused by medical treatment, not addison's disease. In 2016 the patient had a surgery because of serous ovarian cyst. Because she had felt feeble, the physician switched her medication from prednisolone to hydrocortisone (30 mg/day). At this point, the patient has been thought to not have addison? S disease. The customer stated, " at this point, prednisolone and steroid ointment used for nephrotic syndrome treatment are suspected as the cause of endogenous suppression of her tuitary body/adrenal cortex. However there is a possibility of complication with isolated acth deficiency. It is hard to do the correct assessment as long as real acth cannot be measured. Once correct acth values are known, a crh loading test can be done for assessment. " as cortisol has been low, the physician does not believe the patient has cushing's disease. Dhea-s => 273 ng/ml expected range: 0,354? 2,56 ng/ml. Tsh => 0. 854 - iu/ml expected range: 0,27? 4,20 - iu/ml. Ft4 => 1. 19 ng/dl expected range: 0,93? 1,7 ng/dl. Rheumatoid factor <10, antinuclear antibody x2560 (speckled 2560'). There was no problem with calibration or quality controls on the analyzer. Investigation of the patient's sample sent to the manufacturer suggest a heterophilic antibody that interferes with the reaction causing a falsely increased result. This type of interference is covered in product labeling. For diagnostic purposes, the results should always be assessed in conjunction with the patient? S medical history, clinical examination and other findings. Further clarification of the observed discrepancies is not possible with the available methods or current state of the art.
Patient Sequence No: 1, Text Type: N, H10
[69453229]
Additional sample from the patient was tested for acth on (b)(6) 2017. Acth by the roche method was 348. 1 pg/ml. The result by cleia was 31. 5 pg/ml, which matches the clinical picture of the patient. The patient also had a cortisol of 7. 6 ug/dl before administration of hydrocortisone. Two samples were tested by the siemens immulite method. Acth results for both were < 5 pg/ml. These data support the conclusion the event was caused by a heterophilic antibody in the samples. Further clarification of the observed discrepancies is not possible with available methods and the current state of the art.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01818 |
| MDR Report Key | 6116355 |
| Date Received | 2016-11-21 |
| Date of Report | 2017-03-07 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2016-11-01 |
| Date Added to Maude | 2016-11-21 |
| 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 | ELECSYS ACTH TEST SYSTEM |
| Generic Name | RADIOIMMUNOASSAY, ACTH |
| Product Code | CKG |
| Date Received | 2016-11-21 |
| Model Number | NA |
| Catalog Number | 03255751190 |
| Lot Number | ASKU |
| 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 | 2016-11-21 |