MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-01 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.
[26499144]
(b)(4). A followup report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[26499145]
The account generated false positive bhcg results on 7 patients who repeated negative when processing on the architect i2000sr analyzer. No impact to patient management was reported. Data provided: (b)(6), initial positive architect bhcg of 64. 2 miu/ml, repeat negative of <1. 2 miu/ml. (b)(6), initial positive architect bhcg of 53. 3 miu/ml, repeat negative of <1. 2 miu/ml. (b)(6), initial positive architect bhcg of 25 miu/ml, repeat negative of <1. 2 miu/ml. (b)(6), initial positive architect bhcg of 52. 1miu/ml, repeat negative of <1. 2 miu/ml. (b)(6), initial positive architect bhcg of 86. 1miu/ml, repeat negative of <1. 2 miu/ml. (b)(6), initial positive architect bhcg of 61. 0 miu/ml, repeat negative of 4. 5 miu/ml. (b)(6), initial positive architect bhcg of 65. 4 miu/ml, repeat negative of <1. 2 miu/ml.
Patient Sequence No: 1, Text Type: D, B5
[34411216]
The field service representative (fsr) was dispatched and performed probe precision tests, reviewed instrument logs and observed an issue with the bhcg carryover, performed decontamination procedures with a passing carryover test. No reoccurrence of bhcg carryover has been observed since the fsr site visit. The fsr determined the bhcg result issue was cause by carryover from the stat probe which was contaminated/dirty. The issue was resolved by the fsr performing as needed maintenance procedure, flush fluids. The architect isr07687 result log was reviewed and confirmed the initial stat bhcg (assay id 30) results as specified in the complaint text for sample identification (sid) (b)(4). The result log shows these samples were retested for routine bhcg (assay id 651) instead of stat bhcg, and all the results were <7000. 00 miu/ml (dilution 1:15). Additionally, the result comments confirmed that serum samples were used for the stat bhcg testing. A review of the 12 month search for similar complaints did not identify an adverse trend of the probe. A review of the architect product monitoring identified no trigger associated with the architect i2000sr erratic result rate with no trends were identified for the i2000sr. The bhcg package inserts address sample handling/ performance characteristics, including the recommendation of plasma samples for stat testing. The package insert also addresses how a displayed result of < 7000. 00 miu/ml (1:15 automated dilution protocol) indicates the need to retest the sample at a lower dilution or undiluted. The result and interpretation should not be reported. The architect system operations manual provides information regarding troubleshooting of the described issue. Probable causes and corrective actions for erratic assay results include but are not limited to: the probe is dirty or partially clogged with the corresponding corrective action of performing as needed maintenance procedure, flush fluids. The architect i2000sr is performing acceptably.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2015-00223 |
| MDR Report Key | 5048112 |
| Date Received | 2015-09-01 |
| Date of Report | 2015-11-24 |
| Date Mfgr Received | 2015-10-29 |
| Device Manufacturer Date | 2010-10-29 |
| Date Added to Maude | 2015-09-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | NAL |
| Date Received | 2015-09-01 |
| Catalog Number | 03M74-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-01 |