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 2019-04-17 for ACCESS HFSH REAGENT 33520 manufactured by Beckman Coulter.
[142262806]
Age or date of birth, weight, ethnicity: the customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race. Device evaluated by mfr: the access hfsh reagent was not returned for evaluation. No hardware errors, flags or other assay issues were reported in conjunction with this event. The customer performed linear dilution testing on the patient's sample and obtained non-linear results suggesting a patient-source interferent. In addition, the customer sent sample to a reference laboratory who pre-treated the sample with blocking agents. The result obtained was significantly lower than the customer's result again suggesting the presence of a patient-source interferent of unknown origin. In conclusion, the cause of this event is due to an unknown patient-source interferent.
Patient Sequence No: 1, Text Type: N, H10
[142262807]
The customer contacted beckman coulter (bci) to report obtaining a higher than expected follicle stimulating hormone (access hfsh) result for one female patient on the laboratory? S access 2 immunoassay analyzer serial number (b)(4). The first access hfsh result questioned was on (b)(6) 2019. The customer took the patient off of their birth-control medication at this time. Another sample was collected and tested for access hfsh again; another higher than expected result was obtained. The customer performed linear dilutions and noted that the results obtained were not linear suggesting that a patient-source interferent was present. The patient then had an mri (magnetic resonance imaging) of the head performed which was normal (it is unknown if contrast dye was used). In addition, the patient received treatment with a gnrh (gonadotropin-releasing hormone) antagonist, however, the access hfsh result was still higher than expected. On (b)(6) 2019 a third sample was tested for the access hfsh assay and the result was similar; still elevated. This sample was also sent to a reference laboratory which used a different methodology (type unknown) and pretreatment with a blocking reagent. The result was much lower than the access hfsh result and more in-line with the customer? S expectation based upon the patient? S clinical presentation. There was a change in patient care/management as the patient was taken off of their birth-control medication, underwent an mri of the head and was treated with a gnrh antagonist. There was no report of injury or death associated with this event. The customer did not provide any information as to the instrument? S performance including qc (quality control), calibrations or system check. However, there were no reports of issues with hardware or other patient results or assays. Sample collection and preparation information was not supplied including sample type, centrifugation time and speed and storage conditions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2019-01070 |
| MDR Report Key | 8524260 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-01-31 |
| Date Facility Aware | 2019-03-28 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-04-17 |
| 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 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER |
| 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 HFSH REAGENT |
| Generic Name | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE |
| Product Code | CGJ |
| Date Received | 2019-04-17 |
| Catalog Number | 33520 |
| Lot Number | 724813 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-17 |