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 2018-12-11 for ACCESS TESTOSTERONE 33560 manufactured by Chaska Discrete Mfg Io.
[129932758]
A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site. No hardware errors, flags or other assay issues were reported in conjunction with this incident. There is no evidence that the testosterone reagent was returned for evaluation. A dilution study was performed by the customer on sample six (6) from (b)(6) 2018, as recommended in the information for use (ifu). Per the testosterone instructions for use (ifu), part number a33261, it states? Using weighted cubic regression, the access testosterone assay was linear, with a maximum deviation from linearity of 9. 1% for samples > 1. 4 ng/ml. Samples = 1. 4 ng/ml demonstrated a maximum deviation from linearity of 0. 15 ng/ml.? Heterophile interference is the cause of the elevated testosterone results obtained by the customer as the dilution test carried out by the customer generated non-linear results. The exact nature of interference cannot be determined without further testing. Per the testosterone ifu? For assays employing antibodies, the possibility exists for interference by heterophile antibodies in the patient sample. Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e. G. Hama, that interfere with immunoassays. Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in patient samples. Such interfering antibodies may cause erroneous results. Carefully evaluate the results of patients suspected of having these antibodies.? Beckman coulter has requested a patient sample for interference testing. The customer will sent the sample for investigation if the patient agrees to come back for a re-draw. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129932759]
The customer reported obtaining reproducible high testosterone results for one (1) patient involving the laboratory's unicel dxi 800 immunoassay systems (serial number (b)(4)). Four (4) different samples from this same patient gave high testosterone results between (b)(6) 2017 and (b)(6) 2018. The patient underwent surgical removal of the ovaries in (b)(6) 2018 because of the elevated testosterone results as well as the patient clinical picture. The patient presented hirsutism on the face, bigger than expected ovaries and hair loss. The patient is a (b)(6)-year-old postmenopausal female. No other change to treatment has been reported by the customer. Results post-surgery were discordant to the patient clinical file. Testing on the siemens advia centaur recovered within the expected range. No hardware errors, flags or other assay issues were reported in conjunction with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2018-01034 |
| MDR Report Key | 8151351 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2018-11-22 |
| Device Manufacturer Date | 2017-11-30 |
| Date Added to Maude | 2018-12-11 |
| 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 | MR. DAVID DAVIS |
| Manufacturer Street | 250 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | CHASKA DISCRETE MFG IO |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS TESTOSTERONE |
| Generic Name | ACCESS TESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2018-12-11 |
| Model Number | 33560 |
| Catalog Number | 33560 |
| Lot Number | 724408 |
| Device Expiration Date | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHASKA DISCRETE MFG IO |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-11 |