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 2017-02-07 for ACCESS B12 REAGENT 33000 manufactured by Beckman Coulter.
[66713291]
The customer did not supply patient demographic information such as the patient's exact date of birth and weight. Initial customer's phone is (b)(6). A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's laboratory to verify instrument peformance as there were no hardware errors in conjunction with this event. There is no indication that the customer sent the access b12 reagent to bec for further evaluation. The customer has not sent any patient sample to bec for testing to date. There were no errors, system flags or event log messages in conjunction with this event. In conclusion, the cause of the reproducible, normal access b12 results could not be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
[66713292]
The customer reported obtaining reproducible, normal vitamin b12 (access b12) results for one (1) patient since (b)(6) 2016 on the laboratory's unicel dxi 600 access immunoassay system serial number (b)(4). On (b)(6) 2016 the customer obtained an access b12 result within the normal reference range of the assay for the patient. This sample was then sent to a reference laboratory and tested on an alternate methodology (roche elecsys) which produced a discordant result below the normal reference range of the assay. The normal access b12 results were released from the laboratory. There was a change in patient management in conjunction with the normal access b12 results as the patient's vitamin b12 treatments were delayed until after receiving the roche result in (b)(6) of 2016. System verification parameters such as qc (quality controls), calibrations and system checks were performing within assay and laboratory specifications at the time of the event. There were no reports of issues with other analytes, samples or the hardware in conjunction with this event. The patient's sample was collected in a 5 ml (milliliter) serum tube with a gel separator which was centrifuged for ten (10) minutes at 3,000 rpm (revolutions per minute) at room temperature. There were no reports of any sample integrity issues in conjunction with this event.
Patient Sequence No: 1, Text Type: D, B5
[68793471]
The customer provided one (1) patient sample for interference testing to the beckman coulter (bec) marseilles complaint handling unit (chu). The patient's sample was first tested neat and recovered with an access b12 result within normal reference range of the assay. This result confirmed the reproducible normal results obtained by the customer. Dilution testing was then performed which resulted with non-linear results. Interference testing, using a mix of different blockers including alkaline phosphatase, was then performed. The result of the interference testing did not lower the signal of the patient's sample. This type of interference could not be determined. In conclusion, the investigation demonstrated that some form of unknown interference is the cause of the reproducible normal access b12 results as dilution testing produced non-linear results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2017-00006 |
| MDR Report Key | 6307348 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-07 |
| Date of Report | 2017-01-23 |
| Date of Event | 2016-05-01 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2017-02-07 |
| 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 | MS. ANGELA KILIAN |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681330 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS B12 REAGENT |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2017-02-07 |
| Model Number | NA |
| Catalog Number | 33000 |
| Lot Number | 671102 |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 | 2017-02-07 |