MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-04-09 for ARCHITECT PROLACTIN 07K76-35 manufactured by A.i.d.d Longford.
[72214631]
An evaluation is in process. A final report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[72214632]
The customer observed a falsely elevated prolactin results on the architect i2000sr analyzer. The following data was provided: initial 1,020 miu/l, repeated 300 miu/l on another method. The sample was retested 1,062. 96 miu/l, 1,212. 12 miu/l. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[79038955]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The product was not available for return. An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications. The gold standard process used to determine if macroprolactin is present in a patient sample is to perform size-exclusion chromatography, and then test the fractions for the presence of prolactin. An alternate method of detecting macroprolactin is to use polyethylene glycol (peg) to selectively precipitate the higher molecular weight macroprolactin and compare the results of the supernatant to those from the unprecipitated sample. Significant under-recovery (less than 40 percent) of the supernatant indicates significant macroprolactin is present. Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005094123-2017-00013 |
| MDR Report Key | 6474667 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-09 |
| Date of Report | 2017-04-09 |
| Date Mfgr Received | 2017-03-28 |
| Date Added to Maude | 2017-04-09 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | A.I.D.D LONGFORD |
| Manufacturer Street | LISNAMUCK CO. LONGFORD |
| Manufacturer City | LONGFORD NA |
| Manufacturer Country | EI |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT PROLACTIN |
| Generic Name | PROLACTIN |
| Product Code | CFT |
| Date Received | 2017-04-09 |
| Catalog Number | 07K76-35 |
| Lot Number | 67336UI00 |
| Device Expiration Date | 2017-08-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A.I.D.D LONGFORD |
| Manufacturer Address | LISNAMUCK CO. LONGFORD LONGFORD NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-09 |